FDA Approvals, News & Updates
Officials with the FDA have approved nivolumab (Opdivo; Bristol Myers Squibb)
with ipilimumab (Yervoy; Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma, and other updates. Read More ›
The FDA has approved penpulimab-kcqx (Akeso Biopharma Co, Ltd) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) and as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least 1 other previous line of therapy. Read More ›
Nivolumab (Opdivo; Bristol Myers Squibb) with ipilimumab (Yervoy; Bristol Myers Squibb) is now FDA approved for patients aged ≥12 years with unresectable or metastatic microsatellite instability-high or mismatch repair–deficient colorectal cancer. Read More ›
Officials with the FDA have approved tislelizumab-jsgr (Tevimbra; BeOne Medicines, Ltd, formerly known as BeiGene, Ltd), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express programmed death-ligand 1. Read More ›
Officials with the FDA have granted traditional approval to pembrolizumab (Keytruda; Merck) with trastuzumab- (Herceptin; Genentech), fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥1. Read More ›
Cabozantinib (Cabometyx; Exelixis, Inc) has been approved by the FDA for use in patients aged >12 years who had previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). Read More ›
On March 28, 2025, the FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto; Novartis) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and who are considered appropriate to delay taxane-based chemotherapy. Read More ›
FDA officials recently approved durvalumab (Imfinzi; AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle-invasive bladder cancer. Read More ›
Officials with the FDA recently issued a communication in an attempt to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. Read More ›
Ensartinib (Ensacove; Xcovery Holdings, Inc) has been approved for use in treating adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. Read More ›