FDA delays decision on AstraZeneca’s camizestrant NDA

The US Food and Drug Administration (FDA) has informed AstraZeneca (LSE: AZN) that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for 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.

The NDA is based on positive results from the pivotal SERENA-6 Phase III trial presented at the 2025 American Society of Clinical Oncology (ASCO) 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.