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          Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)Resources for Information | Approved Drugs Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
  
  	
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FDA Drug Information Soundcast in Clinical Oncology (DISCO) 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.







Latest Drug Information Soundcasts

Title
			Date
			Link to Podcast
			Link to Transcript**FDA D.I.S.C.O. Burst Edition: OGSIVEO (nirogacestat)**
			FDA approval of OGSIVEO (nirogacestat) for adult patients with progressing desmoid tumors who require systemic treatment
			November 27, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Augtyro (repotrectinib)**
			FDA approval of Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer
			November 15, 2023
			*Run Time: 00:02:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Fruzaqla (fruquintinib)**
			FDA approval of Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer
			November 8, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tibsovo (ivosidenib)**
			FDA approval of Tibsovo (ivosidenib) for patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation
			October 24, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Talvey (talquetamab-tgvs) and Elrexfio (elranatamab-bcmm)**
			FDA approvals of Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma, and Elrexfio (elranatamab-bcmm) for relapsed or refractory multiple myeloma
			August 2, 2023
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Lynparza (olaparib)**
			FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer
			May 31, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Epkinly (epcoritamab-bysp)**
			FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
			May 19, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition:  Polivy (polatuzumab vedotin-piiq)**
			FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
			April 19, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Omisirge (omidubicel-onlv)**
			FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies
			April 17, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab)**
			FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma
			April 3, 2023
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Zynyz (retifanlimab-dlwr)**
			FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma
			March 22, 2023
			*Run Time: 00:02:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tafinlar (dabrafenib) with Mekinist (trametinib)**
			FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation
			March 16, 2023
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Verzenio (abemaciclib)**
			FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancer
			March 3, 2023
			*Run Time: 00:04:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Jemperli (dostarlimab-gxly)**
			FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancer
			February 9, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Trodelvy (sacituzumab govitecan-hziy)**
			FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer
			February 3, 2023
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Jaypirca (pirtobrutinib) and Orserdu (elacestrant)**
			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
			January 27, 2023
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Keytruda (pembrolizumab)**
			FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancer
			January 26, 2023
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tukysa (tucatinib) and Brukinsa (zanubrutinib)**
			FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma
			January 19, 2023
			*Run Time: 00:06:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Lunsumio (mosunetuzumab-axgb)**
			FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
			December 22, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Adstiladrin (nadofaragene firadenovec-vncg)**
			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
			December 16, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Xeloda (capecitabine)**
			FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewal
			December 14, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tecentriq (atezolizumab) and Krazati (adagrasib)**
			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
			December 9, 2022
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Rezlidhia (olutasidenib)**
			FDA approval of Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation
			December 1, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)**
			FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)
			November 18, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Elahere (mirvetuximab soravtansine-gynx)**
			FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
			November 14, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Adcetris (brentuximab vedotin) in combination with chemotherapy**
			FDA approval of Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients with classical Hodgkin lymphoma
			November 10, 2022
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy**
			FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for metastatic non-small cell lung cancer
			November 10, 2022
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy**
			FDA approval of Libtayo (cemiplimab-rwlc)  in combination with platinum-based chemotherapy for non-small cell lung cancer
			November 8, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Imjudo (tremelimumab) in combination with durvalumab and Tecvayli (teclistamab-cqyv)**
			FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma
			October 21, 2022
			*Run Time: 00:05:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Lytgobi (futibatinib)**
			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
			September 30, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Retevmo (selpercatinib)**
			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 cancer
			September 21, 2022
			*Run Time: 00:06:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Pedmark (sodium thiosulfate)**
			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 tumors
			September 20, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Imfinzi (durvalumab)**
			FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer
			September 2, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition:Imbruvica (ibrutinib) and Pemazyre (pemigatinib)**
			FDA approvals of Imbruvica (ibrutinib)  for pediatric patients 1 year of age or older with chronic graft versus host disease after failure of 1 or more lines of systemic therapy, and Pemazyre (pemigatinib) for adults with relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement
			August 24, 2022
			*Run Time: 00:05:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tabrecta (capmatinib) and Enhertu (fam-trastuzumab deruxtecan-nxki)**
			FDA approvals of Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test, and Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating human epidermal growth factor receptor 2 HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
			August 10, 2022
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki) and Nubeqa (darolutamide) in combination with docetaxel**
			FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki)  for adult patients with unresectable or metastatic HER2-low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, and Nubeqa (darolutamide)  in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer
			August 5, 2022
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib)**
			FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor
			July 14, 2022
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)**
			FDA approval of Breyanzi (lisocabtagene maraleucel) for adult patients with large B-cell lymphoma who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age
			June 24, 2022
			*Run Time: 00:04:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tafinlar (dabrafenib) in combination with Mekinist (trametinib)**
			FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic solid tumors with BRAF V600E mutation
			June 22, 2022
			*Run Time: 00:04:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Opdivo (nivolumab) in combination with chemotherapy, Opdivo (nivolumab) in combination with Yervoy (nivolumab and ipilimumab) and Kymriah (tisagenlecleucel)**
			FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma
			May 27, 2022
			*Run Time: 00:06:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tibsovo (ivosidenib) in combination with azacitidine**
			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
			May 25, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Vidaza (azacytidine)**
			FDA approval of Vidaza (azacytidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia
			May 20, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki)**
			FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy
			May 4, 2022
			*Run Time: 00:04:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Vijoice (alpelisib)**
			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
			April 5, 2022
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel)**
			FDA approval of 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. It is not indicated for the treatment of patients with primary central nervous system lymphoma
			April 1, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Pluvicto (lutetium Lu 177 vipivotide tetraxetan)**
			FDA approval of Pluvicto 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 chemotherapy
			March 23, 2022
			*Run Time: 00:04:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Opdualag (nivolumab and relatlimab-rmbw) and Keytruda (pembrolizumab)**
			FDA approvals of Opdualag (nivolumab and relatlimab-rmbw) for unresectable or metastatic melanoma, and Keytruda (pembrolizumab) for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation
			March 18, 2022
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Opdivo (nivolumab) and Lynparza (olaparib)**
			FDA approvals of Opdivo (nivolumab) for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting, and Lynparza (olaparib)  for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated human epidermal growth factor receptor 2 (or HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib
			March 4, 2022
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: CARVYKTI  (ciltacabtagene autoleucel)**
			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
			February 28, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Kimmtrak (tebentafusp-tebn)**
			FDA approval of Kimmtrak (tebentafusp-tebn) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
			January 25, 2022
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Orencia (abatacept)**
			FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease
			December 15, 2021
			*Run Time: 00:05:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Rituxan (rituximab) and Keytruda (pembrolizumab)**
			FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanoma
			December 2, 2021
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Cytalux (pafolacianine) and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone**
			FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myeloma
			November 29, 2021
			*Run Time: 00:04:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound))**
			FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor
			November 22, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Keytruda (pembrolizumab)**
			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
			November 17, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Scemblix (asciminib)**
			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
			October 29, 2021
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tecentriq (atezolizumab)**
			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
			October 15, 2021
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Verzenio (abemaciclib) and Keytruda (pembrolizumab)**
			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)
			October 12, 2021
			*Run Time: 00:06:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tecartus (brexucabtagene autoleucel)**
			FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
			October 1, 2021
			*Run Time: 00:02:30*
			Transcript**FDA D.I.S.C.O. Burst Edition:Tivdak (tisotumab vedotin-tftv) and Jakafi (ruxolitinib)**
			FDA approvals of Tivdak (tisotumab vedotin-tftv) for adult patients with 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 in adult and pediatric patients 12 years and older
			September 20, 2021
			*Run Time: 00:04:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Cabometyx (cabozantinib)**
			FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer
			September 17, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Brukinsa (zanubrutinib) and Exkivity (mobocertinib)**
			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
			September 14, 2021
			*Run Time: 00:05:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Brukinsa (zanubrutinib)**
			FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia
			August 31, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tibsovo (ivosidenib)**
			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
			August 25, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Jemperli (dostarlimab-gxly) and Opdivo (nivolumab)**
			FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection
			August 17, 2021
			*Run Time: 00:06:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Welireg (belzutifan)**
			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
			August 13, 2021
			*Run Time: 00:06:43*
			Transcript**FDA D.I.S.C.O. Burst Edition: Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab)**
			FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinoma
			August 10, 2021
			*Run Time: 00:03:30*
			Transcript**​FDA D.I.S.C.O. Burst Edition: Keytruda (pembrolizumab)**
			FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer
			July 26, 2021
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib)**
			FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma
			July 21, 2021
			*Run Time: 00:04:41*
			Transcript**FDA D.I.S.C.O. Burst Edition: Rezurok (belumosudil)**
			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
			July 16, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Padcev (enfortumab vedotin-ejfv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj)**
			FDA approves 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
			July 9, 2021
			*Run Time: 00:06:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Rylaze (aspariginase erwinia chrysanthemi (recombinant) - rywn)**
			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.
			June 30, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Ayvakit (avapritinib)**
			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
			June 16, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Lumakras(sotorasib) and Truseltiq (infigratinib)**
			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
			May 28, 2021
			*Run Time: 00:06:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Opdivo (nivolumab) and Rybrevant (amivantamab-vmjw)**
			FDA approvals of Opdivo (nivolumab) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy and Rybrevant (amivantamab-vmjw) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
			May 20, 2021
			*Run Time: 00:05:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Keytruda (pembrolizumab)**
			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
			May 5, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Jemperli (dostarlimab-gxly) and Zynlonta (loncastuximab tesirine-lpyl)**
			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.
			April 22, 2021
			*Run Time: 00:04:59*
			Transcript**FDA D.I.S.C.O. Burst Edition: Trodelvy (sacituzumab govitecan) and Opdivo (nivolumab)**
			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.
			April 13, 2021
			*Run Time: 00:05:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Erbitux (cetuximab) and Trodelvy (sacituzumab govitecan)**
			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.
			April 6, 2021
			*Run Time: 00:05:51*
			Transcript**FDA D.I.S.C.O. Burst Edition: Sarclisa (isatuximab-irfc)**
			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.
			March 31, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Abecma (idecabtagene vicleucel)**
			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.
			March 26, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Keytruda (pembrolizumab)**
			FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma.
			March 22, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Fotivda (tivozanib)**
			FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.
			March 10, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel)**
			FDA approval of Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
			March 5, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib)**
			FDA approval of Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test.
			March 3, 2021
			*Run Time: 00:04:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Pepaxto (melphalan flufenamide)**
			FDA granted approval to melphalan flufenamide (brand name Pepaxto) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.
			February 26, 2021
			*Run Time: 00:03:00*
			Transcript**FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc)**
			FDA approved cemiplimab-rwlc (brand name Libtayo) for the first-line treatment of patients with advanced non-small cell lung cancer (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (a Tumor Proportion Score greater than or equal to 50%) as determined by an FDA-approved test, with no estimated glomerular filtration rate, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations.
			February 22, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc)**
			FDA approved cemiplimab-rwlc (brand name Libtayo) 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.
			February 9, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel)**
			FDA approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (or DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
			February 5, 2021
			*Run Time: 00:03:30*
			Transcript**FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib)**
			FDA approvals of Tepmetko (tepotinib) for adult patients with metastatic non-small cell lung cancer (or NSCLC) harboring mesenchymal-epithelial transition (or MET) exon 14 skipping alterations and Ukoniq (umbralisib) for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.
			February 3, 2021
			*Run Time: 00:07:16*
			Transcript**FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)**
			FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen and combination of nivolumab (brand name Opdivo) and cabozantinib (brand name Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma.
			January 15, 2021
			*Run Time: 00:04:29*
			Transcript**FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase)**
			FDA approvals of Xalkori (crizotinib) for patients 1-21 years with ALK-positive lymphoma and Faspro (daratumumab plus hyaluronidase) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis.
			January 14, 2021
			*Run Time: 00:04:29*
			Transcript**FDA D.I.S.C.O.: Intro by 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.
			May 16, 2017
			*Run Time:
			00:3:19*
			Transcript**FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer**
			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.
			May 17, 2017
			*Run Time:
			00:5:13*
			Transcript**FDA D.I.S.C.O.: Niraparib in Ovarian Cancer**
			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.
			May 18, 2017
			*Run Time:
			00:5:56*
			Transcript**FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma**
			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.
			May 22, 2017
			*Run Time:
			00:6:28*
			Transcript**FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval**
			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.
			May 30, 2017
			*Run Time:
			00:6:00*
			Transcript**FDA D.I.S.C.O.: Two approvals for ALK-positive non-small cell lung cancer**
			FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer.
			July 25, 2017
			*Run Time:
			00:9:00*
			Transcript**FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer**
			FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer.
			July 28, 2017
			*Run Time:
			00:6:00*
			Transcript**FDA D.I.S.C.O.: L-glutamine for sickle cell disease**
			FDA medical oncologists discuss the July 7, 2017, approval of l-glutamine to reduce the acute complications of sickle cell disease.
			August 17, 2017
			*Run Time:
			00:5:29*
			Transcript**FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemia**
			FDA medical oncologists discuss the Aug. 3, 2017, approval of Vyxeos for treatment of acute myelogenous leukemia.
			September 15, 2017
			*Run Time:
			00:4:59*
			Transcript**FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancer**
			FDA medical oncologists discuss the Sept 14, 2017, approval of MVASI, the first biosimilar approved in the US for the treatment of cancer.
			December 21, 2017
			*Run Time:
			00:8:29*
			Transcript**FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapy**
			FDA medical oncologists discuss the first approval of a chimeric antigen receptor (CAR) T-cell immunotherapy.
			February 23, 2018
			*Run Time:
			00:5:59*
			Transcript**FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanoma**
			FDA medical oncologists discuss the December 20, 2017, approval of nivolumab for the adjuvant treatment of patients with melanoma.
			February 26, 2018
			*Run Time:
			00:5:00*
			Transcript**FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancer**
			FDA medical oncologists discuss the February 14, 2018, approval of apalutamide for the treatment of non-metastatic castration-resistant prostate cancer.
			May 3, 2018
			*Run Time:
			00:4:59*
			Transcript**FDA D.I.S.C.O.: A supplemental drug approval for the adjuvant treatment of high risk advanced renal cell cancer**
			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.
			August 16, 2018
			*Run Time:
			00:5:29*
			Transcript**FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer**
			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.
			October 2, 2018
			*Run Time:
			00:5:29*
			Transcript**FDA D.I.S.C.O.: A new drug approval for IDH1 positive relapsed or refractory Acute Myeloid Leukemia**
			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.
			October 18, 2018
			*Run Time:
			00:6:29*
			Transcript**FDA D.I.S.C.O.: FDA approval of moxetumomab pasudotox-tdfk for relapsed or refractory hairy cell leukemia**
			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.
			November 29, 2018
			*Run Time:
			00:8:13*
			Transcript**FDA D.I.S.C.O.: FDA approval of cemiplimab-rwlc for cutaneous squamous cell carcinoma**
			FDA medical oncologists discuss the September 28, 2018, approval of cemiplimab-rwlc for the treatment of select patients with cutaneous squamous cell carcinoma.
			November 30, 2018
			*Run Time:
			00:8:17*
			Transcript**FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusion**
			FDA medical oncologists discuss the Nov. 26, 2018, accelerated approval of larotrectinib for adult and pediatric patients.
			December 13, 2018
			*Run Time:
			00:7:29*
			Transcript**FDA D.I.S.C.O.: FDA approval of cabozantinib for 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.
			March 12, 2019
			*Run Time:
			00:5:29*
			Transcript**FDA D.I.S.C.O.: FDA approval of Cablivi for acquired thrombotic thrombocytopenic purpura**
			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.
			April 12, 2019
			*Run Time:
			00:7:59*
			Transcript



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                                                                                  Content current as of:
      01/08/2024Resources for Information | Approved Drugs

          
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