FDA Expands Keytruda for Head and Neck Cancers

The FDA expanded its approval for Merck’s blockbuster drug Keytruda (pembrolizumab) for head and neck cancers. Doctors can now prescribe Keytruda as a first-line therapy, or in combination with platinum and fluorouracil, for adults with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.

The expanded approval comes after Merck handed up data from a Phase 3 trial, which showed that patients in the Keytruda group had better overall survival rates that patients taking a different chemotherapy regime.

The immunotherapy was already approved for lung and other cancers and this year recorded sales above $2 billion for the first quarter — a new record.