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:
A story is told that after first obtaining approval for marketing Premarin in 1942, Wyeth Laboratories didn’t lock up the secret recipe for making the hormonal drug in a company safe, to be guarded by patent lawyers.
