FDA to Review Merck Drug as First-Line Treatment for Lung Cancer

The U.S. Food and Drug Administration will review Merck & Co.'s immunotherapy cancer drug Keytruda as a first-line treatment for patients with the most common form of lung cancer, the company said Wednesday.

The FDA granted Keytruda, or pembrolizumab, breakthrough therapy designation and priority-review status with a target action date of Dec. 24.

In October, Keytruda was cleared for use as a second-line treatment in patients with non-small-cell 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. Merck is now seeking approval for the drug as a stand-alone treatment option.

Merck's latest submissions were based on data from a pivotal phase 3 Keynote-024 study released in June, which showed that Keytruda monotherapy resulted in superior progression-free survival as well as overall survival compared with standard chemotherapy. The trial was stopped early so patients still on chemotherapy could opt to start treatment with Keytruda.

"Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news," said Dr. Roger Perlmutter, Merck's research chief.

Keytruda, an infused drug, was first 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. It was granted breakthrough status for specific patients with advanced melanoma, metastatic non-small-cell lung cancer in previously treated patients, microsatellite instability high metastatic colorectal cancer, and relapsed or refractory classical Hodgkin lymphoma.

Merck shares, inactive premarket, have risen 20% so far this year.

Write to Anne Steele at [e-mail]

(END) Dow Jones Newswires

September 07, 2016 14:27 ET (18:27 GMT)

Copyright (c) 2016 Dow Jones & Company, Inc.