Data in hand, Merck shoots for Keytruda approval for lung cancer

Merck R&D Chief Roger Perlmutter

Hot on the heels of Bristol-Myers Squibb ($BMY), Merck ($MRK) announced over the weekend that it has filed for FDA approval to market its PD-1 star Keytruda for non-small cell lung cancer. The announcement came along with fresh data to support Merck's case for the checkpoint inhibitor, which is designed to strip cancer cells of their natural defenses against an immune system attack. Merck's analysis of 313 patients concluded that the overall response rate was 45.4% in patients with greater than or equal to 50% of tumor cells positive for PD-L1 expression. "We are encouraged by the new KEYNOTE-001 data evaluating Keytruda in patients with advanced non-small cell lung cancer, which will be presented today at AACR Annual Meeting," said Roger Perlmutter, Merck's R&D chief. "We look forward to the FDA's review of our supplemental application for Keytruda, which is based in part on these data." Keytruda is already approved for melanoma. Release/Release

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