enFDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)falseU.S. Food and Drug Administration, Center for Drug Evaluation and Researchhttps://www.fda.gov/files/OND-OHOP-DISCO-Podcast.pnghttps://www.fda.govFDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)U.S. Food and Drug Administration, Center for Drug Evaluation and ResearchCDERPodcasts@fda.hhs.govhttps://www.fda.gov/drugs/resources-information-approved-drugs/drug-information-soundcast-clinical-oncology-discoFDA D.I.S.C.O. Burst Edition: FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutationMon, 17 Jun 2024 11:00:47 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240617-110047FDA D.I.S.C.O. Burst Edition: FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutationhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-ojemda-tovorafenib-relapsed-or-refractory-pediatric-low-gradefalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumorsFri, 26 Apr 2024 14:29:03 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240426-142903FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumorshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-enhertu-fam-trastuzumab-deruxtecan-nxki-unresectable-orfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of OGSIVEO (nirogacestat) for adult patients with progressing desmoid tumors who require systemic treatmentMon, 08 Jan 2024 13:02:10 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240108-130210FDA D.I.S.C.O. Burst Edition: FDA approval of OGSIVEO (nirogacestat) for adult patients with progressing desmoid tumors who require systemic treatmenthttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-ogsiveo-nirogacestat-adult-patients-progressing-desmoid-tumorsfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancerFri, 05 Jan 2024 14:23:58 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240105-142358FDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-augtyro-repotrectinib-locally-advanced-or-metastatic-ros1false2:59FDA D.I.S.C.O. Burst Edition: FDA approval of Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancerFri, 05 Jan 2024 10:22:38 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20240105-102238FDA D.I.S.C.O. Burst Edition: FDA approval of Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-fruzaqla-fruquintinib-adult-patients-metastatic-colorectalfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutationMon, 20 Nov 2023 14:18:04 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20231120-141804FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutationhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tibsovo-ivosidenib-patients-relapsed-or-refractoryfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approvals of Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma, and Elrexfio (elranatamab-bcmm) for relapsed or refractory multiple myelomaTue, 26 Sep 2023 10:30:44 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230926-103044FDA D.I.S.C.O. Burst Edition: FDA approvals of Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma, and Elrexfio (elranatamab-bcmm) for relapsed or refractory multiple myelomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-talvey-talquetamab-tgvs-relapsed-or-refractory-multiplefalse6:59FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancerThu, 13 Jul 2023 10:01:49 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230713-100149FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-lynparza-olaparib-abiraterone-and-prednisone-brca-mutatedfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphomaWed, 21 Jun 2023 08:54:07 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230621-085407FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-epkinly-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-bfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphomaWed, 07 Jun 2023 13:52:48 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230607-135248FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-polivy-polatuzumab-vedotin-piiq-previously-untreated-diffusefalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignanciesThu, 25 May 2023 10:10:34 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230525-101034FDA D.I.S.C.O. Burst Edition: FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancieshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-omisirge-omidubicel-onlv-reduce-time-neutrophil-recovery-andfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinomaWed, 03 May 2023 16:03:06 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230503-160306FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-padcev-enfortumab-vedotin-ejfv-keytruda-pembrolizumab-locallyfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinomaThu, 20 Apr 2023 09:46:15 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230420-094615FDA D.I.S.C.O. Burst Edition: FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-zynyz-retifanlimab-dlwr-metastatic-or-recurrent-locallyfalse2:30FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutationThu, 06 Apr 2023 08:56:48 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230406-085648FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutationhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tafinlar-dabrafenib-mekinist-trametinib-pediatric-patients-lowfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancerFri, 24 Mar 2023 09:55:53 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230324-095553FDA D.I.S.C.O. Burst Edition: FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-verzenio-abemaciclib-endocrine-therapy-patients-hr-positivefalse4:30FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancerTue, 07 Mar 2023 14:18:33 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230307-141833FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-jemperli-dostarlimab-gxly-dmmr-endometrial-cancerfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancerWed, 01 Mar 2023 11:45:13 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230301-114513FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-trodelvy-sacituzumab-govitecan-hziy-hr-positive-breast-cancerfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma, and Orserdu (elacestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancerWed, 01 Mar 2023 11:44:12 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230301-114412FDA D.I.S.C.O. Burst Edition: FDA approvals of Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma, and Orserdu (elacestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-jaypirca-pirtobrutinib-relapsed-or-refractory-mantle-cellfalse6:59FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancerWed, 01 Mar 2023 11:43:13 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230301-114313FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-adjuvant-treatment-non-small-cell-lungfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphomaThu, 16 Feb 2023 06:34:25 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230216-063425FDA D.I.S.C.O. Burst Edition: FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-tukysa-tucatinib-trastuzumab-colorectal-cancer-and-brukinsafalse6:29FDA D.I.S.C.O. Burst Edition: FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancerMon, 23 Jan 2023 11:54:30 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230123-115430FDA D.I.S.C.O. Burst Edition: FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati (adagrasib) for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-tecentriq-atezolizumab-unresectable-or-metastatic-alveolarfalse6:59FDA D.I.S.C.O. Burst Edition: FDA approval of Adstiladrin (nadofaragene firadenovec-vncg) for patients with high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumorsFri, 20 Jan 2023 06:09:04 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230120-060904FDA D.I.S.C.O. Burst Edition: FDA approval of Adstiladrin (nadofaragene firadenovec-vncg) for patients with high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumorshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-adstiladrin-nadofaragene-firadenovec-vncg-patients-high-riskfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapyThu, 19 Jan 2023 10:38:28 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230119-103828FDA D.I.S.C.O. Burst Edition: FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-lunsumio-mosunetuzumab-axgb-adult-patients-relapsed-orfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project RenewalTue, 17 Jan 2023 16:21:42 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230117-162142FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewalhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-updated-drug-labeling-including-new-indications-and-dosingfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutationTue, 10 Jan 2023 10:31:24 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230110-103124FDA D.I.S.C.O. Burst Edition: FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutationhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-rezlidhia-olutasidenib-relapsed-or-refractory-acute-myeloidfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancerFri, 06 Jan 2023 11:59:30 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20230106-115930FDA D.I.S.C.O. Burst Edition: FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-elahere-mirvetuximab-soravtansine-gynx-fra-positive-platinumfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)Wed, 28 Dec 2022 09:39:35 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221228-093935FDA D.I.S.C.O. Burst Edition: FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-new-dosing-regimen-asparaginase-erwinia-chrysanthemifalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin lymphomaThu, 15 Dec 2022 14:08:58 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221215-140858FDA D.I.S.C.O. Burst Edition: FDA approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin lymphomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-adcetris-brentuximab-vedotin-combination-chemotherapy-pediatricfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancerMon, 05 Dec 2022 16:04:34 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221205-160434FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-libtayo-cemiplimab-rwlc-combination-platinum-based-chemotherapyfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for metastatic non-small cell lung cancerMon, 05 Dec 2022 10:57:01 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221205-105701FDA D.I.S.C.O. Burst Edition: FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for metastatic non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-imjudo-tremelimumab-combination-imfinzi-durvalumab-and-platinumfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myelomaWed, 23 Nov 2022 09:45:06 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221123-094506FDA D.I.S.C.O. Burst Edition: FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myelomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-imjudo-tremelimumab-combination-durvalumab-unresectablefalse5:29FDA D.I.S.C.O. Burst Edition: FDA approval of Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangementsWed, 23 Nov 2022 10:59:26 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221123-105926FDA D.I.S.C.O. Burst Edition: FDA approval of Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangementshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-lytgobi-futibatinib-adult-patients-previously-treatedfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive solid tumors, and Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancerThu, 03 Nov 2022 11:15:50 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221103-111550FDA D.I.S.C.O. Burst Edition: FDA approvals of Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive solid tumors, and Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-retevmo-selpercatinib-adult-patients-locally-advanced-orfalse6:30FDA D.I.S.C.O. Burst Edition: FDA approval of Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumorsWed, 19 Oct 2022 12:36:51 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221019-123651FDA D.I.S.C.O. Burst Edition: FDA approval of Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumorshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-pedmark-sodium-thiosulfate-reduce-risk-ototoxicity-associatedfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancerMon, 17 Oct 2022 13:43:41 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20221017-134341FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-imfinzi-durvalumab-adult-patients-locally-advanced-orfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approvals of Imbruvica (ibrutinib) for pediatric patients with chronic graft versus host disease, and Pemazyre (pemigatinib) for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangementWed, 28 Sep 2022 09:28:13 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220928-092813FDA D.I.S.C.O. Burst Edition: FDA approvals of Imbruvica (ibrutinib) for pediatric patients with chronic graft versus host disease, and Pemazyre (pemigatinib) for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangementhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-imbruvica-ibrutinib-pediatric-patients-chronic-graft-versusfalse5:59FDA D.I.S.C.O. Burst Edition: FDA approvals of Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancerWed, 07 Sep 2022 13:33:37 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220907-133337FDA D.I.S.C.O. Burst Edition: FDA approvals of Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-tabrecta-capmatinib-metastatic-non-small-cell-lung-cancer-andfalse6:59FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancerWed, 07 Sep 2022 13:39:18 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220907-133918FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-enhertu-fam-trastuzumab-deruxtecan-nxki-unresectable-orfalse6:59FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumorMon, 01 Aug 2022 13:37:15 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220801-133715FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumorhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-xalkori-crizotinib-alk-positive-inflammatory-myofibroblasticfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic solid tumors with BRAF V600E mutationMon, 25 Jul 2022 09:32:43 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220725-093243FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic solid tumors with BRAF V600E mutationhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tafinlar-dabrafenib-combination-mekinist-trametinibfalse4:59FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphomaThu, 21 Jul 2022 10:13:22 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220721-101322FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-breyanzi-lisocabtagene-maraleucel-second-line-treatment-large-bfalse4:59FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphomaThu, 23 Jun 2022 13:17:09 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220623-131709FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-opdivo-combination-chemotherapy-and-opdivo-combination-yervoyfalse6:29FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapyFri, 17 Jun 2022 14:18:54 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220617-141854FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tibsovo-ivosidenib-combination-azacitidine-newly-diagnosedfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemiaFri, 03 Jun 2022 12:40:33 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220603-124033FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-vidaza-azacitidine-pediatric-patients-newly-diagnosed-juvenilefalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancerTue, 24 May 2022 10:37:26 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220524-103726FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-enhertu-fam-trastuzumab-deruxtecan-nxki-adult-patientsfalse4:29FDA D.I.S.C.O. Burst Edition: FDA approval of Vijoice (alpelisib) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum who require systemic therapyWed, 27 Apr 2022 09:38:28 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220427-093828FDA D.I.S.C.O. Burst Edition: FDA approval of Vijoice (alpelisib) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum who require systemic therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-vijoice-alpelisib-adult-and-pediatric-patients-two-years-agefalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapyFri, 22 Apr 2022 06:14:35 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220422-061435FDA D.I.S.C.O. Burst Edition: FDA approval Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-yescarta-axicabtagene-ciloleucel-adult-patients-large-b-cellfalse4:00FDA D.I.S.C.O.: Burst Edition: FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapyFri, 22 Apr 2022 06:18:35 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220422-061835FDA D.I.S.C.O.: Burst Edition: FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-pluvicto-lutetium-lu-177-vipivotide-tetraxetan-treatment-adultfalse4:29FDA D.I.S.C.O.: Burst Edition: FDA approvals of Opdualag (nivolumab and relatlimab-rmbw) for unresectable or metastatic melanoma, and Keytruda (pembrolizumab) for patients with advanced endometrial carcinomaFri, 08 Apr 2022 09:31:58 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220408-093158FDA D.I.S.C.O.: Burst Edition: FDA approvals of Opdualag (nivolumab and relatlimab-rmbw) for unresectable or metastatic melanoma, and Keytruda (pembrolizumab) for patients with advanced endometrial carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-opdualag-nivolumab-and-relatlimab-rmbw-unresectable-orfalse6:59FDA D.I.S.C.O. Burst Edition: FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibodyWed, 30 Mar 2022 14:45:52 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220330-144552FDA D.I.S.C.O. Burst Edition: FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibodyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-carvykti-ciltacabtagene-autoleucel-treatment-adult-patientsfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanomaTue, 15 Feb 2022 10:22:35 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220215-102235FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanomafalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host diseaseTue, 18 Jan 2022 13:44:18 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20220118-134418FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host diseasehttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-orencia-abatacept-prophylaxis-acute-graft-versus-host-diseasefalse5:29FDA D.I.S.C.O. Burst Edition: FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanomaFri, 17 Dec 2021 10:26:29 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211217-102629FDA D.I.S.C.O. Burst Edition: FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-rituxan-rituximab-plus-chemotherapy-pediatric-cancerfalse6:59FDA D.I.S.C.O. Burst Edition: FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myelomaThu, 16 Dec 2021 15:10:34 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211216-151034FDA D.I.S.C.O. Burst Edition: FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myelomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-cytalux-pafolacianine-identifying-malignant-ovarian-cancerfalse4:59FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumorMon, 06 Dec 2021 13:48:40 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211206-134840FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumorhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-fyarro-sirolimus-protein-bound-particles-injectable-suspensionfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesionsWed, 24 Nov 2021 09:18:21 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211124-091821FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesionshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-adjuvant-treatment-patients-renal-cellfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with tyrosine kinase inhibitors, and for adult patients in chronic phase with the T315I mutationTue, 09 Nov 2021 14:31:09 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211109-143109FDA D.I.S.C.O. Burst Edition: FDA approval of Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with tyrosine kinase inhibitors, and for adult patients in chronic phase with the T315I mutationhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-scemblix-asciminib-patients-philadelphia-chromosome-positivefalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Tecentriq (atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancerTue, 26 Oct 2021 06:48:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211026-064800FDA D.I.S.C.O. Burst Edition: FDA approval of Tecentriq (atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tecentriq-atezolizumab-adjuvant-treatment-following-resectionfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Verzenio (abemaciclib) for adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer, & Keytruda (pembrolizumab) for persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1)Mon, 25 Oct 2021 12:18:46 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211025-121846FDA D.I.S.C.O. Burst Edition: FDA approvals of Verzenio (abemaciclib) for adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer, & Keytruda (pembrolizumab) for persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1)http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-verzenio-abemaciclib-adjuvant-treatment-adult-patients-hormonefalse6:59FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemiaThu, 14 Oct 2021 09:34:46 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211014-093446FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tecartus-brexucabtagene-autoleucel-adult-patients-relapsed-orfalse2:30FDA D.I.S.C.O. Burst Edition: FDA approvals of Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and Jakafi (ruxolitinib) for chronic graft-versus-host disease after failure of one or two lines of systemic therapyTue, 05 Oct 2021 13:37:07 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211005-133707FDA D.I.S.C.O. Burst Edition: FDA approvals of Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and Jakafi (ruxolitinib) for chronic graft-versus-host disease after failure of one or two lines of systemic therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-tivdak-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervicalfalse4:59FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancerMon, 04 Oct 2021 14:33:58 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20211004-143358FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-cabometyx-cabozantinib-locally-advanced-or-metastaticfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutationsTue, 28 Sep 2021 09:21:31 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210928-092131FDA D.I.S.C.O. Burst Edition: FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutationshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-brukinsa-zanubrutinib-adult-patients-relapsed-or-refractoryfalse5:59FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemiaWed, 15 Sep 2021 11:57:30 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210915-115730FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-brukinsa-zanubrutinib-adult-patients-waldenstromsfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved testTue, 07 Sep 2021 13:04:04 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210907-130404FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved testhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tibsovo-ivosidenib-adult-patients-previously-treated-locallyfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinomaMon, 30 Aug 2021 13:13:28 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210830-131328FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-jemperli-dostarlimab-gxly-patients-mismatch-repair-deficientfalse6:00FDA D.I.S.C.O. Burst Edition: FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinomaWed, 25 Aug 2021 09:50:08 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210825-095008FDA D.I.S.C.O. Burst Edition: FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-lenvima-lenvatinib-combination-keytruda-pembrolizumab-firstfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Welireg (belzutifan) for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgeryWed, 25 Aug 2021 14:21:31 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210825-142131FDA D.I.S.C.O. Burst Edition: FDA approval of Welireg (belzutifan) for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgeryhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-welireg-belzutifan-adult-patients-von-hippel-lindau-disease-whofalse5:00FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancerWed, 11 Aug 2021 13:43:25 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210811-134325FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-high-risk-early-stage-triple-negativefalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinomaFri, 30 Jul 2021 10:47:51 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210730-104751FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-combination-lenvima-lenvatinib-advancedfalse4:00FDA D.I.S.C.O. Burst Edition: FDA approval of Rezurok (belumosudil) for adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapyWed, 28 Jul 2021 11:06:06 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210728-110606FDA D.I.S.C.O. Burst Edition: FDA approval of Rezurok (belumosudil) for adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-rezurok-belumosudil-adult-and-pediatric-patients-12-years-andfalse3:30FDA D.I.S.C.O. Burst Edition: Approval of Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial cancer and Darzalex Faspro (daratumumab and hyaluronidase-fihj) with pomalidomide and dexamethasone for multiple myelomaThu, 22 Jul 2021 10:06:13 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210722-100613FDA D.I.S.C.O. Burst Edition: Approval of Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial cancer and Darzalex Faspro (daratumumab and hyaluronidase-fihj) with pomalidomide and dexamethasone for multiple myelomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-approval-padcev-enfortumab-vedotin-ejfv-locally-advanced-or-metastaticfalse6:29FDA D.I.S.C.O. Burst Edition: FDA approves Rylaze (asparaginase erwinia chrysanthemi (recombinant) - rywn) for ​treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginaseMon, 12 Jul 2021 13:23:50 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210712-132350FDA D.I.S.C.O. Burst Edition: FDA approves Rylaze (asparaginase erwinia chrysanthemi (recombinant) - rywn) for ​treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginasehttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywnfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemiaThu, 24 Jun 2021 12:14:49 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210624-121449FDA D.I.S.C.O. Burst Edition: FDA approval of Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-ayvakit-avapritinib-adult-patients-advanced-systemicfalse3:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangementThu, 17 Jun 2021 08:57:39 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210617-085739FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangementhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-lumakras-sotorasib-patients-kras-g12c-mutated-locally-advancedfalse6:29FDA D.I.S.C.O. Burst Edition: Approval of Opdivo (nivolumab) for resected esophageal or gastroesophageal junction cancer with residual disease who have received chemoradiotherapy and Rybrevant (amivantamab-vmjw) for locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutationsTue, 08 Jun 2021 13:34:10 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210608-133410FDA D.I.S.C.O. Burst Edition: Approval of Opdivo (nivolumab) for resected esophageal or gastroesophageal junction cancer with residual disease who have received chemoradiotherapy and Rybrevant (amivantamab-vmjw) for locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutationshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-approval-opdivo-nivolumab-resected-esophageal-or-gastroesophageal-junctionfalse5:59FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinomaWed, 12 May 2021 12:01:56 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210512-120156FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-combination-trastuzumab-fluoropyrimidinefalse3:00FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for adults with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-lpyl) for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapyThu, 29 Apr 2021 15:26:58 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210429-152658FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for adults with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-lpyl) for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-jemperli-dostarlimab-gxly-adults-mismatch-repair-deficientfalse4:59FDA D.I.S.C.O. Burst Edition: FDA approvals of Trodelvy (sacituzumab govitecan) for locally advanced/metastatic urothelial cancer who received platinum-containing chemotherapy & either PD-1/PD-L1 inhibitor and Opdivo (nivolumab) in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinomaFri, 23 Apr 2021 13:35:39 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210423-133539FDA D.I.S.C.O. Burst Edition: FDA approvals of Trodelvy (sacituzumab govitecan) for locally advanced/metastatic urothelial cancer who received platinum-containing chemotherapy & either PD-1/PD-L1 inhibitor and Opdivo (nivolumab) in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-trodelvy-sacituzumab-govitecan-locally-advancedmetastaticfalse5:29FDA D.I.S.C.O. Burst Edition: FDA approvals of Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for patients with unresectable locally advanced or metastatic triple negative breast cancerFri, 16 Apr 2021 10:01:50 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210416-100150FDA D.I.S.C.O. Burst Edition: FDA approvals of Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for patients with unresectable locally advanced or metastatic triple negative breast cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-erbitux-cetuximab-k-ras-wild-type-egfr-expressing-colorectalfalse4:59FDA D.I.S.C.O. Burst Edition: FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyTue, 13 Apr 2021 11:13:18 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210413-111318FDA D.I.S.C.O. Burst Edition: FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-sarclisa-isatuximab-irfc-combination-carfilzomib-andfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myelomaWed, 07 Apr 2021 11:28:49 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210407-112849FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myelomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-abecma-idecabtagene-vicleucel-first-fda-approved-cell-basedfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinomaMon, 05 Apr 2021 09:06:57 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210405-090657FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-patients-metastatic-or-locally-advancedfalse3:30FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapiesWed, 31 Mar 2021 11:46:14 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210331-114614FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapieshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-fotivda-tivozanib-adult-patients-relapsed-or-refractoryfalse3:00FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapyMon, 22 Mar 2021 12:42:17 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210322-124217FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-yescarta-axicabtagene-ciloleucel-adult-patients-relapsed-or-refractoryfalse3:00FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved testFri, 19 Mar 2021 08:13:35 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210319-081335FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved testhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-lorbrena-lorlatinib-patients-metastatic-non-small-cell-lung-cancer-whosefalse4:00FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapyTue, 16 Mar 2021 09:38:49 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210316-093849FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-approval-pepaxto-melphalan-flufenamide-combination-dexamethasone-adult-patientsfalse3:00FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrationsFri, 12 Mar 2021 06:01:35 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210312-060135FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrationshttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-libtayo-cemiplimab-rwlc-first-line-treatment-patients-advanced-nsclc-locallyfalse3:30FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor (or an HHI) is not appropriateTue, 09 Mar 2021 12:50:43 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210309-125043FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor (or an HHI) is not appropriatehttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-libtayo-cemiplimab-rwlc-patients-locally-advanced-or-metastatic-basal-cellfalse3:30FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)Thu, 04 Mar 2021 16:27:30 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210304-162730FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-breyanzi-lisocabtagene-maraleucelfalse3:30FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib)Mon, 01 Mar 2021 13:51:55 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210301-135155FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib)http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-tepmetko-tepotinib-and-ukoniq-umbralisibfalse5:00FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)Thu, 25 Feb 2021 11:03:31 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210225-110331FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-enhertu-fam-trastuzumab-deruxtecan-nxki-and-combination-opdivo-nivolumab-andfalse4:29FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase)Wed, 17 Feb 2021 12:11:04 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20210217-121104FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase)http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-xalkori-crizotinib-and-darzalex-faspro-daratumumab-plus-hyaluronidasefalseFDA D.I.S.C.O.: FDA approval of Cablivi for acquired thrombotic thrombocytopenic purpuraFri, 12 Apr 2019 13:11:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190412-131100FDA D.I.S.C.O.: FDA approval of Cablivi for acquired thrombotic thrombocytopenic purpurahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-cablivi-acquired-thrombotic-thrombocytopenic-purpurafalse7:59FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinomaTue, 12 Mar 2019 15:05:57 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20190312-150557FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-cabozantinib-hepatocellular-carcinoma FDA medical oncologists discuss the January 14, 2019, approval of cabozantinib for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.]]>false5:30FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusionThu, 13 Dec 2018 14:53:25 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20181213-145325FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusionhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-larotrectinib-advanced-malignancies-ntrk-gene-fusionfalse7:29FDA D.I.S.C.O.: FDA approval of cemiplimab-rwlc for cutaneous squamous cell carcinomaFri, 30 Nov 2018 13:40:22 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20181130-134022FDA D.I.S.C.O.: FDA approval of cemiplimab-rwlc for cutaneous squamous cell carcinomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-cemiplimab-rwlc-cutaneous-squamous-cell-carcinomafalse6:30FDA D.I.S.C.O.: FDA approval of moxetumomab pasudotox-tdfk for relapsed or refractory hairy cell leukemiaThu, 29 Nov 2018 15:47:58 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20181129-154758FDA D.I.S.C.O.: FDA approval of moxetumomab pasudotox-tdfk for relapsed or refractory hairy cell leukemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-moxetumomab-pasudotox-tdfk-relapsed-or-refractory-hairy-cell-leukemiafalse6:30FDA D.I.S.C.O.: A new drug approval for IDH1 positive relapsed or refractory Acute Myeloid LeukemiaThu, 15 Nov 2018 16:22:22 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20181115-162222FDA D.I.S.C.O.: A new drug approval for IDH1 positive relapsed or refractory Acute Myeloid Leukemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-new-drug-approval-idh1-positive-relapsed-or-refractory-acute-myeloid-leukemiafalse6:29FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer Tue, 23 Oct 2018 12:08:48 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20181023-120848FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-olaparib-gbrcam-her2-negative-metastatic-breast-cancerfalse5:30FDA D.I.S.C.O.: A supplemental drug approval for the adjuvant treatment of high risk advanced renal cell cancer - TranscriptThu, 16 Aug 2018 11:44:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180816-114400FDA D.I.S.C.O.: A supplemental drug approval for the adjuvant treatment of high risk advanced renal cell cancer - Transcripthttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-supplemental-drug-approval-adjuvant-treatment-high-risk-advanced-renal-cell-cancerfalse5:29FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancerThu, 03 May 2018 12:12:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180503-121200FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-new-drug-approval-non-metastatic-castration-resistant-prostate-cancerfalse4:59FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapyFri, 23 Feb 2018 11:08:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180223-110800FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapyhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-first-fda-approval-car-t-cell-immunotherapyfalse5:59FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanomaMon, 26 Feb 2018 10:42:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20180226-104200FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanomahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-nivolumab-adjuvant-treatment-patients-melanomafalse5:00FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancerThu, 21 Dec 2017 09:07:00 ESTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20171221-090700FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-first-biosimilar-approval-treatment-cancer
FDA medical oncologists discuss the Sept 14, 2017, approval of MVASI, the first biosimilar approved in the US for the treatment of cancer.]]>
false8:29
FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemiaFri, 15 Sep 2017 13:30:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170915-133000FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemiahttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-new-treatment-acute-myelogenous-leukemia FDA medical oncologists discuss the Aug. 3, 2017, approval of Vyxeos for treatment of acute myelogenous leukemia.]]>false4:59FDA D.I.S.C.O.: L-glutamine for sickle cell diseaseFri, 18 Aug 2017 09:49:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170818-094900FDA D.I.S.C.O.: L-glutamine for sickle cell diseasehttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-l-glutamine-sickle-cell-diseasefalse5:29FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung CancerFri, 28 Jul 2017 13:47:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170728-134700FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-osimertinib-non-small-cell-lung-cancer FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer.]]>false6:00FDA D.I.S.C.O.: Two approvals for ALK-positive non-small cell lung cancerTue, 25 Jul 2017 15:33:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170725-153300FDA D.I.S.C.O.: Two approvals for ALK-positive non-small cell lung cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-two-approvals-alk-positive-non-small-cell-lung-cancerfalse9:00FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma TranscriptMon, 22 May 2017 15:04:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170522-150400FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma Transcripthttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-avelumab-merkel-cell-carcinoma-transcript FDA medical oncologists discuss the agency’s March 23, 2017, approval of avelumab the treatment of patients 12 years and older with metastatic Merkel cell carcinoma.]]>false6:28FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval TranscriptTue, 30 May 2017 17:48:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170530-174800FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcripthttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-first-tissuesite-agnostic-approval-transcript Transcript]]>false6:00FDA D.I.S.C.O.: Niraparib in Ovarian Cancer TranscriptThu, 18 May 2017 16:15:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170518-161500FDA D.I.S.C.O.: Niraparib in Ovarian Cancer Transcripthttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-niraparib-ovarian-cancer-transcriptfalse5:57FDA D.I.S.C.O.: Niraparib in Ovarian CancerThu, 18 May 2017 15:44:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170518-154400FDA D.I.S.C.O.: Niraparib in Ovarian Cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-niraparib-ovarian-cancerfalseFDA D.I.S.C.O.: Rucaparib in Ovarian CancerWed, 17 May 2017 16:27:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170517-162700FDA D.I.S.C.O.: Rucaparib in Ovarian Cancerhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-rucaparib-ovarian-cancer FDA medical oncologists discuss the agency’s December 2016 accelerated approval of rucaparib for treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer who have been treated with two or more chemotherapies.]]>false5:13FDA D.I.S.C.O.: Intro by Dr. Richard PazdurWed, 17 May 2017 16:28:00 EDTU.S. Food and Drug Administration, Center for Drug Evaluation and Research20170517-162800FDA D.I.S.C.O.: Intro by Dr. Richard Pazdurhttp://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-intro-dr-richard-pazdur In our inaugural podcast, Dr. Richard Pazdur, director of the FDA Oncology Center of Excellence, talks with hosts Dr. Sanjeeve Bala and Dr. Abhilasha Nair about this new podcast series.]]>false3:20