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

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.

- FDA D.I.S.C.O. Burst Edition: FDA approval of OGSIVEO (nirogacestat) for adult patients with progressing desmoid tumors who require systemic treatment 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 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 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 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 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
- FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer Listen to a soundcast of the May 31, 2023, FDA approval of Lynparza&#160;(olaparib), with&#160;abiraterone and prednisone,&#160;for BRCA-mutated metastatic castration-resistant prostate cancer.”
- FDA D.I.S.C.O. Burst Edition: 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 May 19, 2023, FDA approval of Epkinly (epcoritamab-bysp)&#160;for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
- FDA D.I.S.C.O. Burst Edition: 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 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.
- FDA D.I.S.C.O. Burst Edition: 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 17, 2023, FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma Listen to a soundcast of the April 19, 2023, FDA approval of Padcev (enfortumab vedotin-ejfv) with&#160;Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma.”
- FDA D.I.S.C.O. Burst Edition: FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell 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.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation 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
- 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 Listen to a soundcast of the March 3, 2023, FDA approval of Verzenio (abemaciclib)&#160;with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancer.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab-gxly) for dMMR endometrial cancer Listen to a soundcast of the February 9, 2023, FDA approval of Jemperli&#160;(dostarlimab-gxly) for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer Listen to a soundcast of the February 3, 2023, FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer.
- 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 or metastatic breast cancer Listen to a soundcast of the January 27, 2023, FDA approvals of Jaypirca&#160;(pirtobrutinib)&#160;for relapsed or refractory mantle cell lymphoma, and Orserdu (elacestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) as adjuvant treatment for non-small cell lung cancer Listen to a soundcast of the January 26, 2023, FDA approval of Keytruda (pembrolizumab)&#160;as&#160;adjuvant treatment for non-small cell lung cancer
- 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 Listen to a soundcast of the January 19, 2023, FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib)&#160;for chronic lymphocytic leukemia or small lymphocytic lymphoma.
- 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 metastatic non-small cell lung cancer 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”
- 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 carcinoma in situ with or without papillary tumors 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.
- 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 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.”
- 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 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.
- 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 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 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
- FDA D.I.S.C.O. Burst Edition: FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant) 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 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
- 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 Listen to a soundcast of the November 8th 2022  FDA approval of Libtayo (cemiplimab-rwlc) &#160;in combination with platinum-based chemotherapy for non-small cell lung cancer
- 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 Listen to a soundcast of the November 10th 2022 FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab)&#160;and platinum-based chemotherapy for metastatic non-small cell lung cancer
- 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 refractory multiple myeloma 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.
- 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 fibroblast growth factor receptor 2 gene fusions or other rearrangements 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.
- 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 patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer 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.
- 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-metastatic solid tumors 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.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer 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.
- 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 myeloid/lymphoid neoplasms with FGFR1 rearrangement 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.”
- 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 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.
- 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 for metastatic hormone-sensitive prostate cancer 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.”
- FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor Listen to a soundcast of the July 14, 2022 FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor.
- 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 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 FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma
- 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 Listen to a soundcast of the May 27, 2022 FDA approvals of Opdivo (nivolumab)&#160;and Yervoy (nivolumab and ipilimumab) for&#160;advanced or metastatic esophageal squamous cell carcinoma,&#160;and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma.&quot;”
- 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 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.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacitidine) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia 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.
- 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 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.
- 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 Listen to a soundcast of the 4/5/2022 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.
- 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 Listen to a soundcast of the April 1st 2022 FDA approval of Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
- 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 castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy Listen to a soundcast of the March 23, 2022 FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for metastatic castration-resistant prostate cancer
- 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 Listen to a soundcast of the March 18, 2022, and March 21, 2022, FDA approvals of Opdualag (nivolumab and relatlimab-rmbw) for unresectable or metastatic melanoma, and Keytruda (pembrolizumab), for advanced endometrial carcinoma.
- 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 Listen to a soundcast of the 2/28/2022 FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody.
- FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma Listen to a soundcast of the January 25, 2022 FDA approval of Kimmtrak (tebentafusp-tebn) for HLA-A*02&#58;01-positive adult patients with unresectable or metastatic uveal melanoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease Listen to a soundcast of the December 15, 2021 FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease.
- 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 Listen to a soundcast of the December 2 and 3, 2021, FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanoma.
- 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 Listen to a soundcast of the November 29, 2021 and November 30, 2021 FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myeloma.
- 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 Listen to a soundcast of the November 22, 2021, FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.
- 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 Listen to a soundcast of the November 17, 2021 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.
- 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 Listen to a soundcast of the October 29, 2021, 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
- 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 Listen to a soundcast of the October 15, 2021 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.
- 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) FDA approvals of Verzenio (abemaciclib) for adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer, &amp; Keytruda (pembrolizumab) for persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥
- 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 Listen to a soundcast of the October 1, 2021 FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
- 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 Listen to a soundcast of the September 20 and 22, 2021, 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
- FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer Listen to a soundcast of the September 17, 2021 FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer.
- 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 Listen to a soundcast of the September 14, and 15, 2021, FDA approvals of Brukinsa (zanubrutinib), for relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small lung cancer.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia Listen to a soundcast of the August 31, 2021 FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia
- 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 Listen to a soundcast of the August 25, 2021 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
- 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 Listen to a soundcast of the August 17, 2021, and August 19, 2021, 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
- 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 Listen to a soundcast of the August 10, 2021 FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinoma
- 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 Listen to a soundcast of the August 8, 2021, FDA approval of Welireg (belzutifan) for 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
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer Listen to a soundcast of the July 26, 2021 FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma Listen to a soundcast of the July 21, 2021 FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma
- 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 Listen to a soundcast of the July 16, 2021 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.
- 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 Listen to a soundcast of the July 9, 2021 FDA approvals 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.
- 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 Listen to a soundcast of the July 1, 2021 FDA approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant) - rywn) for ​treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who have developed hypersensitivity to E. coli-derived asparaginase.​
- 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 Listen to a soundcast of the June 16, 2021 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
- 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 Listen to a soundcast of the May 28, 2021, approvals of Lumakras for patients with KRAS G12C‐mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion.
- 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 Opdivo (nivolumab) for patients w/ resected esophageal/GEJ cancer w/ residual pathologic disease who have received neoadjuvant chemoradiotherapy & Rybrevant (amivantamab-vmjw) for adult patients with locally advanced/metastatic NSCLC w/ epidermal growth factor receptor exon 20 insertion mutations
- 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 Listen to a soundcast of the May 5, 2021 FDA approval of Keytruda (pembrolizumab) combined with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable/ metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.
- 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 Listen to a soundcast of the April 22 & 23 2021 FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-ipyl) for relapsed or refractory large B-cell lymphoma.
- 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 Trodelvy (sacituzumab govitecan) for locally advanced/metastatic urothelial cancer who received platinum-containing chemotherapy & either PD-1/PD-L1 inhibitor. Opdivo (nivolumab) in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma.
- 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 Listen to a soundcast of April 6th & 7th 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 unresectable locally advanced or metastatic triple negative breast cancer.
- 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 Listen to a soundcast of the March 31, 2021 FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
- 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 Listen to a soundcast of the March 26, 2021 FDA approval of ABECMA (idacabtagene vicleucel) the first cell-based gene therapy for treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma.
- 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 Listen to a soundcast of the March 10, 2021 FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.
- 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 Listen to a soundcast of the March 5, 2021 FDA approval of Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
- 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 Listen to a soundcast of the March 3, 2021 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.
- 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 Listen to a soundcast of the February 26, 2021 FDA approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adults patients with refractory multiple myeloma who received at least four prior lines of therapy.
- 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 Listen to a soundcast of the February 22nd 2021 FDA approval of 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
- 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 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
- FDA D.I.S.C.O. Burst Edition: Breyanzi (lisocabtagene maraleucel) Listen to a soundcast of the Feb 5th 2021 FDA approval of Breyanzi for treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
- FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib) Tepmetko (tepotinib): metastatic NSCLC harboring mesenchymal-epithelial transition exon 14 skipping alterations. Ukoniq (umbralisib): relapsed/refractory marginal zone lymphoma with at least 1 prior anti-CD20 regimen & relapsed/refractory follicular lymphoma with at least 3 prior systemic therapies.
- FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) Enhertu (fam-trastuzumab deruxtecan-nxki) for locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma and received a prior trastuzumab-based regimen. Combination of Opdivo (nivolumab) + Cabometyx (cabozantinib) as first-line treatment for advanced renal cell carcinoma
- FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase) FDA D.I.S.C.O.: Update on two recent FDA cancer drug approvals
- 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.
- FDA D.I.S.C.O.: FDA approval of cabozantinib for hepatocellular carcinoma 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.
- FDA D.I.S.C.O.: FDA approval of larotrectinib for advanced malignancies with NTRK gene fusion FDA medical oncologists discuss the accelerated approval of larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
- 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.
- 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
- 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.
- 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.
- FDA D.I.S.C.O.: A supplemental drug approval for the adjuvant treatment of high risk advanced renal cell cancer - Transcript 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.
- FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancer FDA D.I.S.C.O.: A new drug approval for non-metastatic castration-resistant prostate cancer
- 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.
- 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.
- FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancer FDA D.I.S.C.O.: First biosimilar approval for the treatment of cancerFDA medical oncologists discuss the Sept 14, 2017, approval of MVASI, the first biosimilar approved in the US for the treatment of cancer.
- FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemia FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemiaFDA medical oncologists discuss the Aug. 3, 2017, approval of Vyxeos for treatment of acute myelogenous leukemia.
- FDA D.I.S.C.O.: L-glutamine for sickle cell disease 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.
- FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung CancerFDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer.
- 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.
- FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma Transcript FDA D.I.S.C.O.: Avelumab in Merkel Cell CarcinomaFDA 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.
- FDA D.I.S.C.O.: First Tissue/Site Agnostic Approval Transcript 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.Transcript
- FDA D.I.S.C.O.: Niraparib in Ovarian Cancer Transcript 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.
- 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.
- FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer FDA D.I.S.C.O.: Rucaparib in Ovarian CancerFDA 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.
- FDA D.I.S.C.O.: Intro by Dr. Richard Pazdur 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.