FDA APPROVALS

The U.S. 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). Read full press release.

The U.S. 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. Read full press release. 

The U.S. 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. Read full press release.

The U.S. Food and Drug Administration granted accelerated approval to tazemetostat (Tazverik; Epizyme) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Read full press release.

The U.S. Food and Drug Administration approved neratinib (Nerlynx; Puma Biotechnology) 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. Read full press release.

The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) 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. Read full press release.

The U.S. Food and Drug Administration approved olaparib (Lynparza; AstraZeneca) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev; Astellas) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Read full press release.

The U.S. Food and Drug Administration approved enzalutamide (Xtandi; Astellas) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Read full press release.