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FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C...

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research
99 EPISODES
Jun 2022
All Episodes
FDA 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 cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 lymphoma
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 met
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 carc
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 therapy
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewal
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 refractor
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 f
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 pa
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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-metas
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 my
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 mutation
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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, a
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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-ap
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 requi
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 mo
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA 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 castrati
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 ca
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 th
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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) a
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 perivascula
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 nephre
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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-p
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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) f
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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 local
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia
U.S. Food and Drug Administration, Center for Drug Evaluation and Research