30 April 2026

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote on the benefit risk profile of AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor (HR)-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.

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