Overview
- U.S. regulators have formally extended their review of camizestrant after an FDA advisory panel earlier raised questions about the design of a key late-stage trial rather than the drug’s safety.
- AstraZeneca has submitted the additional analyses the FDA asked for and will present longer-term efficacy data at a scientific meeting on June 2.
- The trial strategy at issue tests a mutation-guided switch to camizestrant for patients whose tumors carry a specific genetic change, and advisers said survival and later progression results remain too immature to prove long-term benefit.
- Europe’s drug committee recently recommended approval, creating a split between regulators as the U.S. delays while seeking more mature evidence.
- AstraZeneca said it will continue discussions with the FDA to try to bring the drug to eligible U.S. patients quickly, and the outcome could affect access to a targeted oral therapy for those with the specific tumor mutation.