en FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) false U.S. Food and Drug Administration, Center for Drug Evaluation and Research https://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.gov https://www.fda.gov/drugs/resources-information-approved-drugs/drug-information-soundcast-clinical-oncology-disco FDA 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 lymphoma Thu, 23 Jun 2022 13:17:09 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220623-131709 FDA 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 lymphoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-opdivo-combination-chemotherapy-and-opdivo-combination-yervoy false 6:29 FDA 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 chemotherapy Fri, 17 Jun 2022 14:18:54 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220617-141854 FDA 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 chemotherapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tibsovo-ivosidenib-combination-azacitidine-newly-diagnosed false 4:00 FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia Fri, 03 Jun 2022 12:40:33 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220603-124033 FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-vidaza-azacitidine-pediatric-patients-newly-diagnosed-juvenile false 3:30 FDA 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 cancer Tue, 24 May 2022 10:37:26 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220524-103726 FDA 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 cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-enhertu-fam-trastuzumab-deruxtecan-nxki-adult-patients false 4:29 FDA 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 therapy Wed, 27 Apr 2022 09:38:28 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220427-093828 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-vijoice-alpelisib-adult-and-pediatric-patients-two-years-age false 3:30 FDA 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 chemoimmunotherapy Fri, 22 Apr 2022 06:14:35 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220422-061435 FDA 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 chemoimmunotherapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-yescarta-axicabtagene-ciloleucel-adult-patients-large-b-cell false 4:00 FDA 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 carcinoma Fri, 08 Apr 2022 09:31:58 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220408-093158 FDA 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 carcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-opdualag-nivolumab-and-relatlimab-rmbw-unresectable-or false 6:59 FDA 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 antibody Wed, 30 Mar 2022 14:45:52 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220330-144552 FDA 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 antibody http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-carvykti-ciltacabtagene-autoleucel-treatment-adult-patients false 4:00 FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma Tue, 15 Feb 2022 10:22:35 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220215-102235 FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma false 4:00 FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease Tue, 18 Jan 2022 13:44:18 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20220118-134418 FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-orencia-abatacept-prophylaxis-acute-graft-versus-host-disease false 5:29 FDA 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 melanoma Fri, 17 Dec 2021 10:26:29 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211217-102629 FDA 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 melanoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-rituxan-rituximab-plus-chemotherapy-pediatric-cancer false 6:59 FDA 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 myeloma Thu, 16 Dec 2021 15:10:34 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211216-151034 FDA 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 myeloma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-cytalux-pafolacianine-identifying-malignant-ovarian-cancer false 4:59 FDA 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 tumor Mon, 06 Dec 2021 13:48:40 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211206-134840 FDA 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 tumor http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-fyarro-sirolimus-protein-bound-particles-injectable-suspension false 3:00 FDA 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 lesions Wed, 24 Nov 2021 09:18:21 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211124-091821 FDA 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 lesions http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-adjuvant-treatment-patients-renal-cell false 3:30 FDA 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 mutation Tue, 09 Nov 2021 14:31:09 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211109-143109 FDA 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 mutation http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-scemblix-asciminib-patients-philadelphia-chromosome-positive false 4:00 FDA 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 cancer Tue, 26 Oct 2021 06:48:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211026-064800 FDA 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 cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tecentriq-atezolizumab-adjuvant-treatment-following-resection false 4:00 FDA 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 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211025-121846 FDA 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-hormone false 6:59 FDA 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 leukemia Thu, 14 Oct 2021 09:34:46 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211014-093446 FDA 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 leukemia http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tecartus-brexucabtagene-autoleucel-adult-patients-relapsed-or false 2:30 FDA 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 therapy Tue, 05 Oct 2021 13:37:07 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211005-133707 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-tivdak-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical false 4:59 FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer Mon, 04 Oct 2021 14:33:58 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20211004-143358 FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-cabometyx-cabozantinib-locally-advanced-or-metastatic false 3:00 FDA 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 mutations Tue, 28 Sep 2021 09:21:31 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210928-092131 FDA 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 mutations http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-brukinsa-zanubrutinib-adult-patients-relapsed-or-refractory false 5:59 FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia Wed, 15 Sep 2021 11:57:30 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210915-115730 FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-brukinsa-zanubrutinib-adult-patients-waldenstroms false 3:00 FDA 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 test Tue, 07 Sep 2021 13:04:04 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210907-130404 FDA 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 test http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-tibsovo-ivosidenib-adult-patients-previously-treated-locally false 3:00 FDA 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 carcinoma Mon, 30 Aug 2021 13:13:28 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210830-131328 FDA 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 carcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-jemperli-dostarlimab-gxly-patients-mismatch-repair-deficient false 6:00 FDA 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 carcinoma Wed, 25 Aug 2021 09:50:08 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210825-095008 FDA 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 carcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-lenvima-lenvatinib-combination-keytruda-pembrolizumab-first false 3:30 FDA 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 surgery Wed, 25 Aug 2021 14:21:31 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210825-142131 FDA 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 surgery http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-welireg-belzutifan-adult-patients-von-hippel-lindau-disease-who false 5:00 FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer Wed, 11 Aug 2021 13:43:25 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210811-134325 FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-high-risk-early-stage-triple-negative false 4:00 FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma Fri, 30 Jul 2021 10:47:51 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210730-104751 FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-combination-lenvima-lenvatinib-advanced false 4:00 FDA 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 therapy Wed, 28 Jul 2021 11:06:06 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210728-110606 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-rezurok-belumosudil-adult-and-pediatric-patients-12-years-and false 3:30 FDA 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 myeloma Thu, 22 Jul 2021 10:06:13 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210722-100613 FDA 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 myeloma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-approval-padcev-enfortumab-vedotin-ejfv-locally-advanced-or-metastatic false 6:29 FDA 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 asparaginase Mon, 12 Jul 2021 13:23:50 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210712-132350 FDA 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 asparaginase http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywn false 3:30 FDA 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 leukemia Thu, 24 Jun 2021 12:14:49 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210624-121449 FDA 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 leukemia http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-ayvakit-avapritinib-adult-patients-advanced-systemic false 3:00 FDA 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 rearrangement Thu, 17 Jun 2021 08:57:39 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210617-085739 FDA 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 rearrangement http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-lumakras-sotorasib-patients-kras-g12c-mutated-locally-advanced false 6:29 FDA 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 mutations Tue, 08 Jun 2021 13:34:10 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210608-133410 FDA 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 mutations http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-approval-opdivo-nivolumab-resected-esophageal-or-gastroesophageal-junction false 5:59 FDA 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 adenocarcinoma Wed, 12 May 2021 12:01:56 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210512-120156 FDA 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 adenocarcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-combination-trastuzumab-fluoropyrimidine false 3:00 FDA 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 therapy Thu, 29 Apr 2021 15:26:58 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210429-152658 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-jemperli-dostarlimab-gxly-adults-mismatch-repair-deficient false 4:59 FDA 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 adenocarcinoma Fri, 23 Apr 2021 13:35:39 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210423-133539 FDA 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 adenocarcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-trodelvy-sacituzumab-govitecan-locally-advancedmetastatic false 5:29 FDA 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 cancer Fri, 16 Apr 2021 10:01:50 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210416-100150 FDA 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 cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-erbitux-cetuximab-k-ras-wild-type-egfr-expressing-colorectal false 4:59 FDA 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 therapy Tue, 13 Apr 2021 11:13:18 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210413-111318 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-sarclisa-isatuximab-irfc-combination-carfilzomib-and false 3:30 FDA 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 myeloma Wed, 07 Apr 2021 11:28:49 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210407-112849 FDA 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 myeloma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-abecma-idecabtagene-vicleucel-first-fda-approved-cell-based false 3:30 FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma Mon, 05 Apr 2021 09:06:57 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210405-090657 FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-keytruda-pembrolizumab-patients-metastatic-or-locally-advanced false 3:30 FDA 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 therapies Wed, 31 Mar 2021 11:46:14 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210331-114614 FDA 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 therapies http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-fotivda-tivozanib-adult-patients-relapsed-or-refractory false 3:00 FDA 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 therapy Mon, 22 Mar 2021 12:42:17 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210322-124217 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-yescarta-axicabtagene-ciloleucel-adult-patients-relapsed-or-refractory false 3:00 FDA 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 test Fri, 19 Mar 2021 08:13:35 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210319-081335 FDA 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 test http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-lorbrena-lorlatinib-patients-metastatic-non-small-cell-lung-cancer-whose false 4:00 FDA 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 therapy Tue, 16 Mar 2021 09:38:49 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210316-093849 FDA 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 therapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-approval-pepaxto-melphalan-flufenamide-combination-dexamethasone-adult-patients false 3:00 FDA 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 aberrations Fri, 12 Mar 2021 06:01:35 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210312-060135 FDA 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 aberrations http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-libtayo-cemiplimab-rwlc-first-line-treatment-patients-advanced-nsclc-locally false 3:30 FDA 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 appropriate Tue, 09 Mar 2021 12:50:43 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210309-125043 FDA 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 appropriate http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-libtayo-cemiplimab-rwlc-patients-locally-advanced-or-metastatic-basal-cell false 3:30 FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel) Thu, 04 Mar 2021 16:27:30 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210304-162730 FDA 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-maraleucel false 3:30 FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib) Mon, 01 Mar 2021 13:51:55 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210301-135155 FDA 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-umbralisib false 5:00 FDA 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 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210225-110331 FDA 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-and false 4:29 FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase) Wed, 17 Feb 2021 12:11:04 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20210217-121104 FDA 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-hyaluronidase false FDA D.I.S.C.O.: FDA approval of Cablivi for acquired thrombotic thrombocytopenic purpura Fri, 12 Apr 2019 13:11:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190412-131100 FDA D.I.S.C.O.: FDA approval of Cablivi for acquired thrombotic thrombocytopenic purpura http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-cablivi-acquired-thrombotic-thrombocytopenic-purpura false 7:59 FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinoma Tue, 12 Mar 2019 15:05:57 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20190312-150557 FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinoma http://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.]]> false 5:30 FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusion Thu, 13 Dec 2018 14:53:25 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20181213-145325 FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusion http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-larotrectinib-advanced-malignancies-ntrk-gene-fusion false 7:29 FDA D.I.S.C.O.: FDA approval of cemiplimab-rwlc for cutaneous squamous cell carcinoma Fri, 30 Nov 2018 13:40:22 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20181130-134022 FDA D.I.S.C.O.: FDA approval of cemiplimab-rwlc for cutaneous squamous cell carcinoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-cemiplimab-rwlc-cutaneous-squamous-cell-carcinoma false 6:30 FDA D.I.S.C.O.: FDA approval of moxetumomab pasudotox-tdfk for relapsed or refractory hairy cell leukemia Thu, 29 Nov 2018 15:47:58 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20181129-154758 FDA D.I.S.C.O.: FDA approval of moxetumomab pasudotox-tdfk for relapsed or refractory hairy cell leukemia http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-fda-approval-moxetumomab-pasudotox-tdfk-relapsed-or-refractory-hairy-cell-leukemia false 6:30 FDA D.I.S.C.O.: A new drug approval for IDH1 positive relapsed or refractory Acute Myeloid Leukemia Thu, 15 Nov 2018 16:22:22 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20181115-162222 FDA D.I.S.C.O.: A new drug approval for IDH1 positive relapsed or refractory Acute Myeloid Leukemia http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-new-drug-approval-idh1-positive-relapsed-or-refractory-acute-myeloid-leukemia false 6:29 FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer Tue, 23 Oct 2018 12:08:48 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20181023-120848 FDA 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-cancer false 5:30 FDA D.I.S.C.O.: A supplemental drug approval for the adjuvant treatment of high risk advanced renal cell cancer - Transcript Thu, 16 Aug 2018 11:44:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180816-114400 FDA D.I.S.C.O.: A supplemental drug approval for the adjuvant treatment of high risk advanced renal cell cancer - Transcript http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-supplemental-drug-approval-adjuvant-treatment-high-risk-advanced-renal-cell-cancer false 5:29 FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancer Thu, 03 May 2018 12:12:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180503-121200 FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-new-drug-approval-non-metastatic-castration-resistant-prostate-cancer false 4:59 FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapy Fri, 23 Feb 2018 11:08:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180223-110800 FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapy http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-first-fda-approval-car-t-cell-immunotherapy false 5:59 FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanoma Mon, 26 Feb 2018 10:42:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20180226-104200 FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanoma http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-nivolumab-adjuvant-treatment-patients-melanoma false 5:00 FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancer Thu, 21 Dec 2017 09:07:00 EST U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20171221-090700 FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancer http://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.]]>
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FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemia Fri, 15 Sep 2017 13:30:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170915-133000 FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemia http://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.]]> false 4:59 FDA D.I.S.C.O.: L-glutamine for sickle cell disease Fri, 18 Aug 2017 09:49:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170818-094900 FDA D.I.S.C.O.: L-glutamine for sickle cell disease http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-l-glutamine-sickle-cell-disease false 5:29 FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer Fri, 28 Jul 2017 13:47:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170728-134700 FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer http://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.]]> false 6:00 FDA D.I.S.C.O.: Two approvals for ALK-positive non-small cell lung cancer Tue, 25 Jul 2017 15:33:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170725-153300 FDA D.I.S.C.O.: Two approvals for ALK-positive non-small cell lung cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-two-approvals-alk-positive-non-small-cell-lung-cancer false 9:00 FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma Transcript Mon, 22 May 2017 15:04:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170522-150400 FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma Transcript http://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.]]> false 6:28 FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcript Tue, 30 May 2017 17:48:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170530-174800 FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcript http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-first-tissuesite-agnostic-approval-transcript Transcript]]> false 6:00 FDA D.I.S.C.O.: Niraparib in Ovarian Cancer Transcript Thu, 18 May 2017 16:15:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170518-161500 FDA D.I.S.C.O.: Niraparib in Ovarian Cancer Transcript http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-niraparib-ovarian-cancer-transcript false 5:57 FDA D.I.S.C.O.: Niraparib in Ovarian Cancer Thu, 18 May 2017 15:44:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170518-154400 FDA D.I.S.C.O.: Niraparib in Ovarian Cancer http://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-niraparib-ovarian-cancer false FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer Wed, 17 May 2017 16:27:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170517-162700 FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer http://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.]]> false 5:13 FDA D.I.S.C.O.: Intro by Dr. Richard Pazdur Wed, 17 May 2017 16:28:00 EDT U.S. Food and Drug Administration, Center for Drug Evaluation and Research 20170517-162800 FDA D.I.S.C.O.: Intro by Dr. Richard Pazdur http://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.]]> false 3:20