FDA approves Keytruda for first-line treatment of head and neck squamous cell carcinoma
The FDA approved pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. The approval includes two indications: for use in combination with platinum and fluorouracil for all patients, and as a single agent for patients whose tumors express PD-L1 — with a combined positive score of 1 or greater — as determined by an FDA-approved test. The FDA also expanded its approval of PD-L1 IHC 22C3 pharmDx kit (Agilent) to include use as a companion diagnostic to select patients for treatment for this indication.