FDA Approves Keytruda (Pembrolizumab) for Head and Neck Cancer

The US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) to treat people with head and neck squamous cell carcinoma that has spread or come back after previous chemotherapy treatment. It’s the first immunotherapy drug approved for head and neck cancer. Keytruda is already approved for melanoma and non-small cell lung cancer.

The FDA based its approval on a clinical trial of 174 people with head and neck squamous cell carcinoma that had spread or come back after they were treated with platinum-based chemotherapy. Tumors shrank or disappeared in 16% of the participants who were given Keytruda. The improvement lasted for 6 months or longer in 82% of the people who responded.

“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,” said Dr. Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago, in a statement. “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.”

The FDA acted under its accelerated approval program for drugs that show early promise against a serious disease. The company that makes the drug must submit additional clinical information after approval to demonstrate its benefit. Two large clinical trials are already in progress.

Keytruda is given as an infusion into the vein. The most common side effects are fatigue, cough, nausea, itchy skin, rash, decreased appetite, constipation, joint pain, and diarrhea. Less common but more serious side effects can include inflammation of the lung, colon, hormone-producing glands, liver, and other organs.

Keytruda is manufactured by Merck & Co.

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