Keytruda (pembrolizumab) filed with FDA for head and neck cancer- Merck Inc.

The FDA has accepted for review the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), from Merck Inc., for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for Keytruda as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of 9 August. The sBLA will be reviewed under the FDA’s Accelerated Approval program.

Keytruda is indicated in the United States for the treatment of patients with unresectable or metastatic melanoma. Keytruda is also indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. The NSCLC indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.