AstraZeneca to ‘continue to work with FDA’ after vote against camizestrant

AstraZeneca (AZN) issued the following update on FDA advisory committee vote on camizestrant in combination with a cdk4/6 inhibitor for advanced hr-positive breast cancer: “The US Food and Drug Administration’s Oncologic Drugs Advisory Committee did not reach a majority vote on the benefit risk profile of AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation, based on the SERENA-6 Phase III trial. The Committee voted 3 to 6. In July 2025, the FDA accepted the New Drug Application for camizestrant in combination with a CDK4/6 inhibitor based on positive results from the pivotal SERENA-6 Phase III trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. The FDA granted Breakthrough Therapy Designation for the camizestrant combination in this setting in May 2025. The FDA is not bound by the Committee’s guidance but takes its advice into consideration. AstraZeneca will continue to work with the FDA as it completes its review of the application.”