The U.S. Food and Drug Administration (FDA) has granted priority review designation to Merck's Keytruda (pembrolizumab) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
The company is seeking approval to use the pharmaceutical as a single agent in treatment at a dose of 200 mg administered intravenously every three weeks, according to the company. Multiple studies are moving forward with the drug as a single agent and in combination with chemotherapy.
Currently, pembrolizumab, a humanized monoclonal antibody, is indicated for use in patients with unresectable or metastatic melanoma and for some patients with metastatic non-small cell lung cancer.
"Starting in the early days of our development program, we have explored the role of Keytruda for patients with head and neck cancer," stated Roger Dansey, MD, senior vice president and therapeutic area head of oncology late-stage development at Merck Research Laboratories.
