The FDA pushed back its decision date on AstraZeneca’s oral SERD camizestrant for certain advanced breast cancer patients following a negative outcome from an FDA advisory committee. AstraZeneca said the review extension will allow regulators to assess additional analyses submitted by the company. External advisers last month questioned the SERENA-6 study design and raised concerns that the evidence base lacked sufficient support for key endpoints, including limited survival data and unclear patient quality-of-life benefit. AstraZeneca’s proposed regimen combines camizestrant with the AKT inhibitor Truqap for HER2-negative, HR-positive ESR1-mutant disease. European regulators have recommended approval, but the U.S. review timeline now extends, leaving clinicians and payers awaiting a final call. The delay keeps the drug’s U.S. uptake contingent on the expanded FDA materials. The development underscores how endpoint interpretation and trial design scrutiny continue to drive review timing in next-generation endocrine therapy settings.