FDA Drug Safety Podcasts https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm en-us U.S. Food and Drug Administration, Center for Drug Evaluation and Research FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) is an FDA podcast series that provides information about new product approvals, emerging safety information for cancer treatments, and other current topics in cancer drug development. Center for Drug Evaluation and Research druginfo@fda.hhs.gov (CDER Division of Drug Information) no Thu, 21 Dec 2017 12:35 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) FDA medical oncologists discuss the February 6, 2019, approval of caplacizumab-yhdp for acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. Thu, 12 Apr 2019 11:13 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, oncology, cablivi, caplacizumab-yhdp, acquired thrombotic thrombocytopenic purpura, aTTP, plasma exchange, immunosuppressive therapy, thrombotic microangiopathy FDA medical oncologists discuss the January 14, 2019, approval of cabozantinib for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Tue, 12 Mar 2019 1:47 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, cabozantinib, hepatocellular carcinoma, HCC, oncology, oral inhibitor, cMET, VEGFR2 tyrosine kinases, Cabometyx tablets FDA medical oncologists discuss the Nov. 26, 2018, accelerated approval of larotrectinib for adult and pediatric patients. Thu, 13 Dec 2018 14:43 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, larotrectinib, advanced malignancies, NTRK gene fusion, neurotrophic receptor tyrosine kinase, Vitrakvi,cancer, carcinoma, oncology, FDA medical oncologists discuss the September 28, 2018, approval of cemiplimab-rwlc for the treatment of select patients with cutaneous squamous cell carcinoma. Thu, 30 Nov 2018 11:36 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, metastatic, cemiplimab-rwlc, cemiplimab, cutaneous squamous cell, cancer, carcinoma, oncology, FDA medical oncologists discuss the Sept. 13, 2018, approval of moxetumomab pasudotox-tdfk for the treatment of patients with relapsed or refractory hairy cell leukemia. Thu, 29 Nov 2018 14:51 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, moxetumomab pasudotox-tdfk, Lumoxiti, hairy cell, leukemia, relapsed, refractory, cancer, carcinoma, oncology, FDA medical oncologists discuss the July 2018 approval of ivosidenib for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Thu, 18 Oct 2018 14:30 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, ivosidenib, acute myeloid leukemia, AML, IDH1 mutation, Tibsovo, cancer, carcinoma, oncology, FDA medical oncologists discuss the January 12, 2018, approval of olaparib, the first PARP inhibitor approved for the treatment of patients with metastatic breast cancer with a germline BRCA mutation. Tue, 2 Oct 2018 13:30 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, olaparib, HER2 negative, germline BRCA-mutations, metastatic breast cancer, cancer, Lynparza, carcinoma, oncology, FDA medical oncologists discuss the November 2017 approval of sunitinib for the adjuvant treatment of patients with renal cell carcinoma who are at high risk of recurrence following a nephrectomy. Thu, 16 Aug 2018 1:30 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, sutent, cancer, sunitinib malate, renal cell carcinoma, nephrectomy, carcinoma, S-TRAC, oncology, Pfizer FDA medical oncologists discuss the February 14, 2018, approval of apalutamide for the treatment of non-metastatic castration-resistant prostate cancer. Wed, 03 Mar 2018 11:39 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, apalutamide, cancer, oncology, prostrate, non-metastatic, castration-resistant, prostate specific antigen, PSA, androgen receptor antagonist FDA medical oncologists discuss the December 20, 2017, approval of nivolumab for the adjuvant treatment of patients with melanoma. Mon, 26 Feb 2018 10:56 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, nivolumab, cancer, oncology, melanoma, adjuvant treatment, Opdivo, relapse risk FDA medical oncologists discuss the first approval of a chimeric antigen receptor (CAR) T-cell immunotherapy. Fri, 23 Feb 2018 11:23 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, kymriah, cancer, oncology, CAR T-cell, immunotherapy, acute lymphoblastic leukemia FDA medical oncologists discuss the Sept 14, 2017, approval of MVASI, the first biosimilar approved in the US for the treatment of cancer. Thu, 21 Dec 2017 13:43 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, biosimilar, cancer, oncology, MVASI, bevacizumab-awwb, Avastin FDA medical oncologists discuss the Aug. 3, 2017, approval of Vyxeos for treatment of acute myelogenous leukemia. Fri, 15 Sep 2017 13:43 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, AML, acute myelogenous leukemia, Vyxeos, liposome, daunorubicin, cytarabine FDA medical oncologists discuss the July 7, 2017, approval of l-glutamine to reduce the acute complications of sickle cell disease. Fri, 18 Aug 2017 9:50 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, L-glutamine , sickle cell disease, endari, hemoglobinopathy FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer. Fri, 28 Jul 2017 11:30 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, Osimertinib , cancer, oncology, non-small cell lung cancer, TAGRISSO, tumor FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer. Tue, 25 Jul 2017 12:35 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, brigatinib, ceritinib, cancer, oncology, ALK-positive non-small cell lung cancer, ALK, tumor The D.I.S.C.O. hosts discuss the agency's first approval of a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Tue, 30 May 2017 17:37 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, Pembrolizumab, cancer, oncology, biomarker, tumor 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. Tue, 23 May 2017 07:00 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, Avelumab, cancer, oncology, BRCA, mutation, chemotherapy FDA medical oncologists discuss the agency's March 2017 approval of niraparib for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Thu, 18 May 2017 12:00 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, Niraparib, Ovarian Cancer, oncology, BRCA, mutation, chemotherapy FDA medical oncologists discuss the agency's 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. Wed, 17 May 2017 16:00 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm FDA, Rucaparib, Ovarian Cancer, oncology, BRCA, mutation, chemotherapy 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. Tue, 16 May 2017 18:00 EDT https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm558268.htm https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm558268.htm FDA, new podcast, Richard Pazdur, Sanjeeve Bala, Abhilasha Nair, Oncology, Center, Excellence