Merck's Keytruda gets FDA nod for head and neck cancer

The US Food and Drug Administration granted accelerated approval to for pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) 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 approval was based on demonstration of a durable objective response rate (ORR) in a subgroup of patients in an international, multicenter, non-randomized, open-label, multi-cohort study. This subgroup included 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy.

This is the third approval for Keytruda, adding to its clearance for the treatment of lung cancer and melanoma. The drug has been competing closely with Bristol-Myers Squibb's checkpoint inhibitor Opdivo (nivolumab).