Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. This is the second Breakthrough Therapy Designation granted for Keytruda.

“The FDA’s Breakthrough Therapy Designation of Keytruda underscores that new treatment approaches for advanced non-small cell lung cancer continue to be needed,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “Our data investigating the use of Keytruda in this difficult-to-treat malignancy are very encouraging, and we look forward to working closely with the FDA to expedite our clinical program.”

For more details, go to: http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-receives-fda-breakthrough-therapy-designation-keytruda-pembroli