The FDA delayed its decision on AstraZeneca’s camizestrant, an oral SERD for breast cancer, after an advisory committee voted against approval for the proposed setting. The additional time is intended to allow the agency to review additional data requested by regulators. One report says the review extension follows concerns from outside advisers about the Phase 3 SERENA-6 study design and questions around survival endpoints and quality-of-life signals. External advisors previously recommended against the label expansion described by the company. AstraZeneca did not disclose the new target decision date in the update, leaving uncertainty for patients and clinicians planning sequencing strategies. Regulatory momentum will hinge on the updated analyses AstraZeneca provides and the FDA’s interpretation of benefit-risk evidence for camizestrant in combination with background therapies.