ARTICLE | Regulation
PARP withdrawals showcase evolving role for OS in cancer approvals
Overall survival may be losing its status as the key efficacy outcome of confirmatory cancer trials, but FDA takes OS seriously as safety signal
March 26, 2024 1:27 AM UTC
Overall survival is not the rigid primary endpoint requirement in cancer trials that it once was, but FDA still makes companies collect the data for safety reasons. In revoking approvals of three PARP inhibitors, FDA has once again shown it is maintaining a firm line against drugs that make survival worse.
FDA issued a federal register statement Monday announcing that it was revoking the late-line ovarian cancer approvals of Lynparza olaparib from AstraZeneca plc (LSE:AZN; NASDAQ:AZN), Rubraca rucaparib from Clovis Oncology Inc. and Zejula niraparib from GSK plc (LSE:GSK; NYSE:GSK). ...