FDA Extends Decision Date for AstraZeneca's Breast Cancer Drug Camizestrant

AstraZeneca PLC announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) for camizestrant. The extension is to allow for the review of additional data requested by the FDA. Camizestrant is being considered for combination therapy as a first-line treatment for patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer who have an emergent ESR1 mutation.

The company has submitted further analyses, including data on circulating tumor DNA (ctDNA) clearance linked to longer-term efficacy outcomes, as requested by the FDA. These results are scheduled to be presented at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting. The NDA is based on positive outcomes from the pivotal SERENA-6 Phase III trial, which were simultaneously published in The New England Journal of Medicine.

Earlier in 2026, the FDA's Oncologic Drugs Advisory Committee did not reach a majority vote favoring the benefit of switching to camizestrant in combination with a CDK4/6 inhibitor after the detection of an ESR1 mutation in ctDNA, prior to radiographic progression. The combination therapy previously received Breakthrough Therapy Designation in May 2025.

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval for the camizestrant combination in this setting in May 2026, based on the SERENA-6 trial results. The drug is already approved in the United Arab Emirates and Saudi Arabia, with regulatory applications under review in other countries.