FDA Announces Newly Approved Treatment Options
4/1/2020
New advancements in oncology treatment just announced! The FDA recently released their list of newly approved drugs and treatment combinations available to cancer patients.
Small Cell Lung Cancer
- Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Approved March 30, 2020 | More Information
- Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
- Liver Cancer
- Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Approved March 10, 2020 | More Information
- Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
- Multiple Myeloma
- Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Approved March 2, 2020 | More Information
- Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
- Breast Cancer
- Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Approved February 25, 2020 | More Information
- Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
- Sarcoma
- Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Approved January 23, 2020 | More Information
- Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
- Gastrointestinal Stromal Tumor (GIST)
- Food and Drug Administration approved avapritinib (AYVAKIT, Blueprint Medicines Corporation) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.
Approved January 9, 2020 | More Information
- Food and Drug Administration approved avapritinib (AYVAKIT, Blueprint Medicines Corporation) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.
- Bladder Cancer
- Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Approved January 8, 2020 | More Information
- Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
