The FDA extended its decision timeline on AstraZeneca’s oral breast cancer drug camizestrant, following an FDA advisory committee vote against approval for the proposed use. AstraZeneca said the additional time will support review of extra analyses it submitted, after advisors raised concerns about the pivotal SERENA-6 trial’s design and the evidentiary package. In the company’s application, camizestrant is intended for combination therapy in a molecularly defined population, and AstraZeneca pointed to Phase 3 results showing reduced risk of disease progression or death. External advisors, however, questioned elements of the trial conduct and the adequacy of survival and quality-of-life evidence. For biotech developers, the delay reinforces how trial design and endpoint substantiation can still dominate review timelines even when efficacy signals exist in registrational programs.