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

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: 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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