Overview
- Kennedy told senators Wednesday he had nothing to do with the RP1 decision and said FDA Commissioner Marty Makary told him every review panel opposed approval.
- The FDA rejected RP1 on April 10 because the study paired the drug with Opdivo in a single arm, which the agency said made it impossible to isolate RP1’s effect and required data from a well-controlled trial, and an HHS spokesperson said career scientists and senior biologics leaders reached that view unanimously.
- Cancer doctors challenged Kennedy’s account in a Wall Street Journal op-ed, saying an initial FDA panel supported approval before biologics chief Vinay Prasad overruled it and noting trial patients received immunotherapy, not chemotherapy.
- Replimune reeled from the decision, with shares down about 70% since the rejection and more than 200 layoffs in Massachusetts, though the stock jumped about 15% after the op-ed questioned the agency’s stance.
- Leadership turnover, including Prasad’s planned departure and oncology chief Richard Pazdur’s retirement, plus new guidance for some individualized therapies, has added to investor and biotech worry about less predictable review standards.