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.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
Listen to a soundcast of the 12.18.2024 FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients.
FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
Listen to a soundcast of the 8.2.2024 FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma.
Listen to a soundcast of the 9.17.2024 FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma.
Listen to a soundcast of the June 13, 2024, and June 21, 2024, Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer.
Listen to a soundcast of the May 29, 2024, FDA approval of Retevmo (selpercatinib) for patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
Listen to a soundcast of the April 23, 2024, FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
Listen to a soundcast of the April 5, 2024, FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors.
Listen to a soundcast of the November 27, 2023 FDA approval of OGSIVEO (nirogacestat) for adult patients with progressing desmoid tumors who require systemic treatment.
FDA D.I.S.C.O. Burst Edition: FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer
FDA D.I.S.C.O. Burst Edition: FDA approval of Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer
FDA 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 mutation
FDA 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 myeloma
Listen to a soundcast of the May 31, 2023, FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer.”
Listen to a soundcast of the May 19, 2023, FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
Listen to a soundcast of the April 19, 2023, FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma.
Listen to a soundcast of the April 17, 2023, FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies.
Listen to a soundcast of the April 19, 2023, FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma.”
Lsten to a soundcast of the March 22, 2023 FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma.
Listen to a soundcast of the March 16, 2023, FDA approval of Tafinlar (dabrafenib) for pediatric patients with low-grade glioma with a BRAF V600E mutation
Listen to a soundcast of the March 3, 2023, FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancer.
Listen to a soundcast of the February 9, 2023, FDA approval of Jemperli (dostarlimab-gxly) for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen.
Listen to a soundcast of the February 3, 2023, FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer.
Listen to a soundcast of the January 27, 2023, 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 cancer.
Listen to a soundcast of the January 26, 2023, FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancer
Listen to a soundcast of the January 19, 2023, FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Listen to a soundcast of the December 9 and 12, 2022, 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 cancer”
Listen to a soundcast of the December 16, 2022, 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 tumors.
Listen to a soundcast of the December 22, 2022, FDA approval of Lunsumio (mosunetuzumab-axgb) for ipatients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.”
Listen to a soundcast of the December 14, 2022, FDA approval of Xeloda (capecitabine) under Project Renewal, an initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
Listen to a soundcast of the December 1, 2022, FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation.
FDA 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 cancer
Listen to a soundcast of the November 18, 2022 FDA approval of a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant).
FDA D.I.S.C.O. Burst Edition: FDA approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma
Listen to a soundcast of the November 8th 2022 FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer
Listen to a soundcast of the November 10th 2022 FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for metastatic non-small cell lung cancer
Listen to a soundcast of the 9/30/22 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 rearrangements.
Listen to a soundcast of the October 21st and 25th 2022, FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma.
Listen to a soundcast of the 9/21/22 FDA approval of Retevmo (selpercatinib) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection gene fusion that have progressed on or following prior systemic treatment.
Listen to a soundcast of the September 20, 2022, the FDA approved sodium thiosulfate (brand name Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors.
Listen to a soundcast of the September 2nd, 2022 FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer.
Listen to a soundcast of the 8/24/22 and 8/26/22 FDA approvals of Imbruvica (ibrutinib) for pediatric patients with chronic graft versus host disease, including a new oral suspension, and Pemazyre (pemigatinib) for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.”
Listen to a soundcast of the 8/5/2022 FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for patients unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) for adult patients with metastatic hormone-sensitive prostate cancer.”
Listen to a soundcast of the 8/10/2022 and 8/11/2022 FDA approvals of Tabrecta (capmatinib) for metastatic non-small cell lung cancer, and Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic non-small cell lung cancer.
Listen to a soundcast of the July 14, 2022 FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor.
Listen to a soundcast of the June 22nd 2022 FDA approval of Tafinlar (dabrafenib) for in combination w/trametinib (brand name Mekinist) for unresectable or metastatic solid tumors with BRAF V600E mutation.
FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma
Listen to a soundcast of the May 27, 2022 FDA approvals of Opdivo (nivolumab) and Yervoy (nivolumab and ipilimumab) for advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma."”
Listen to a soundcast of the 05/25/022, FDA approval of Tibsovo (ivosidenib) 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.
Listen to a soundcast of the May 20, 2022, the FDA approved azacitidine (brand name Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia.
Listen to a soundcast of the 5/4/2022 FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer.