FDA to Review Merck's Keytruda for Head and Neck Cancer

By Anne Steele 

The U.S. Food and Drug Administration has accepted Merck & Co.'s supplemental biologics license application for its immunotherapy cancer drug for patients with head and neck cancer, the pharmaceutical company said Wednesday.

The FDA granted pembrolizumab, or Keytruda, priority review status with a target action date of Aug. 9.

Keytruda, an infused drug, was approved in 2014 for the treatment of melanoma. Then, it was a new type of immunotherapy, in a category of treatments that harness the immune system to fight cancer. In October, it cleared for use in patients with non-small-cell lung cancer -- the most common form of lung cancer -- whose tumors contain a certain level of a protein known as PD-L1, and whose disease continued to worsen after the patient received chemotherapy or other drugs.

Pembrolizumab was the first so-called PD-1 inhibitor to hit the U.S. market. The drugs block a protein called programmed death receptor 1, or PD-1, which acts as a brake on certain immune-system cells to prevent them from attacking healthy tissue. Cancer cells can escape destruction by latching onto PD-1; PD-1 inhibitors block this interaction at the site of the tumor, releasing the immune system brake and allowing it to destroy the cancer.

Merck is now seeking approval for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.

"Starting in the early days of our development program, we have explored the role of Keytruda for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options," said Dr. Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development at Merck Research Laboratories. "We are encouraged by the data emerging from our program in this type of cancer."

Write to Anne Steele at [e-mail]

(END) Dow Jones Newswires

April 13, 2016 08:21 ET (12:21 GMT)

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