The FDA pushed back its decision date on AstraZeneca’s oral SERD camizestrant after a negative advisory committee vote tied to SERENA-6. FDA reviewers requested additional analyses to support the application, including issues raised by external advisors around study design and the evidence package for benefit. AstraZeneca is seeking an indication in advanced breast cancer, proposing use in combination with the AKT blocker Truqap in ESR1-mutant, HER2-negative, HR-positive disease. The development puts a spotlight on how trial switching points and endpoint depth factor into regulatory determinations for next-generation endocrine strategies. For the field, the pause highlights the sensitivity of SERD label decisions to the structure of pivotal evidence and the availability of survival and quality-of-life data, especially for first-line settings.