FDA Approvals, News & Updates
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 ›
Remestemcel-L-rknd (Ryoncil; Mesoblast), the first allogeneic bone marrow–derived mesenchymal stromal cell therapy, has been FDA-approved for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients aged ≥2 months. Read More ›
Officials with the FDA have granted accelerated approval to encorafenib (Braftovi; Array BioPharma, a subsidiary of Pfizer) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test. 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 ›
Officials with the FDA have approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; Bristol Myers Squibb) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of combination therapy. Read More ›
Fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) has been approved by FDA officials for use in patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, who have progressed on one or more endocrine therapies in the metastatic setting. Read More ›