Keytruda Receives Two New Approvals in Japan

Merck’s anti-PD-1 therapy, Keytruda, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of patients with PD-L1-positive esophageal squamous cell carcinoma who have progressed after chemotherapy and for a six-week dosing schedule across all adult indications.

According to an Aug. 24, 2020 press release, these latest approvals means that Keytruda now has 13 indications across seven tumor types plus MSI-H tumors in Japan. The approval for use in patients with esophageal squamous cell carcinoma has been based on results from the global Phase III KEYNOTE-181 trial. For the six-week dosing schedule, the approval has been based on pharmacokinetic modeling and exposure-response analyses.

“We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories, in the press release. “With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving Keytruda will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”