August 8, 2016
Merck has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®(pembrolizumab). It is the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication for KEYTRUDA is approved under the FDA’s accelerated approval regulations, based on tumor response rate and durability of response.
Dr. Roger M. Perlmutter, president, Merck Research Laboratories, said: “Today’s approval represents a meaningful advance for the oncology community, as well as for our head and neck cancer clinical program. 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.”
“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. 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,” said Dr. Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago.