FDA Accepts Keytruda sBLA

FDA has accepted for review an sBLA for Merck’s Keytruda (pembrolizumab) for treating patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Merck says that its application seeks approval for Keytruda as a single agent at a dose of 200 mg administered intravenously every three weeks. FDA has given the application priority review and will consider it under the accelerated approval program with a PDUFA action date of 8/9.

Keytruda is described as a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It currently is indicated for treating patients with unresectable or metastatic melanoma and also for treating patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.