Merck recently announced that Keytruda has been approved in Japan due to its ability to treat patients who have PD-L1 positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC).
Keytruda will be used in first-line and second-line treatments as a fixed 200mg dose every third week. Merck will handle manufacturing and marketing of Keytruda. Taiho Pharmaceutical will help with the promotion of the drug.
“This approval in both the first and second-line settings for advanced non-small cell lung cancer in patients whose tumors express PD-L1 marks an important milestone in Japan,” Merck Research Laboratories President Dr. Roger Perlmutter said. “Through advanced research, Merck is demonstrating its commitment to bringing meaningful therapeutic advances to people with cancer throughout the world.”
The approval of Keytruda by the Japanese Ministry of Health, Labour and Welfare (MHLW) came after findings from the two clinical trials, KEYNOTE-024 and KEYNOTE-010, supported the decision.
The KEYNOTE-024 phase 3 trial, which was randomized and open-label, assessed Keytruda as a monotherapy at a 200mg fixed dose, comparing it to the standard of care. The KEYNOTE-010 phase 2/3 study, which was randomized and open-label, evaluated Keytruda in two different dosing options in comparison to docetaxel.
