FDA ODAC vote on camizestrant in breast cancer

On May 1, 2026, AstraZeneca PLC reported that the US FDA's Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote in favor of the benefit-risk profile of camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer with an emergent ESR1 mutation. The committee voted 3-6 against the application, despite the pivotal SERENA-6 Phase III trial showing a 56% reduction in the risk of disease progression or death. The FDA, while not bound by the committee's guidance, will consider their advice. AstraZeneca remains confident in the drug's potential and will continue to collaborate with the FDA during their review. The SERENA-6 trial demonstrated significant improvements in progression-free survival (PFS) and a notable benefit in delaying disease progression and maintaining quality of life. Regulatory applications for camizestrant are also under review in the EU, Japan, and other countries. The company is committed to advancing innovative treatments for breast cancer patients.