Merck said Keytruda (pembrolizumab), an anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency, including three expanded uses in advanced non-small lung cancer, one in melanoma, as well as a new indication in advanced microsatellite instability-high tumors. The following new approvals were all granted priority review by the PMDA:
The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
