FDA approves KEYTRUDA

The U.S. Food and Drug Administration (FDA) recently approved Merck’s anti-PD-1 therapy, KEYTRUDA, for use in fixed doses of 200 mg on a tri-weekly basis for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in patients. 

KEYTRUDA (pembrolizumab) was approved due to the tumor response rate and the strength of the response.

“Today’s approval represents a meaningful advance for the oncology community, as well as for our head and neck cancer clinical program,” President of Merck Research Laboratories Dr. Roger M. Perlmutter said. “Together with prior approvals in the treatment of other tumor types, today’s action by the FDA underscores our tireless commitment to addressing the unmet needs of patients suffering from a broad range of cancers.”

Asociate Director, Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago Dr. Tanguy Seiwert noted the difficulty of treating this type of cancer.

“Head and neck cancer is a complex disease that historically has been associated with high recurrence rates and poor long-term outcomes, highlighting the critical need for new treatment options,” Seiwert said. “The approval of KEYTRUDA for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma is an important step forward in treating this disease.”