FDA Advisory Committee votes against AstraZeneca's camizestrant for breast cancer

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote in favor of the benefit-risk profile of AstraZeneca’s camizestrant in combination with a CDK4/6 inhibitor for the first-line treatment of advanced HR-positive breast cancer with emergent ESR1 mutations. The committee voted 3 to 6.

The decision was based on results from the SERENA-6 Phase III trial, which showed the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard of care. Median progression-free survival (PFS) was 16.0 months for the camizestrant combination versus 9.2 months in the comparator arm. Patient-reported outcomes also indicated benefits in quality of life.

AstraZeneca expressed disappointment with the committee's recommendation but stated they will continue to work with the FDA as it completes its review. The FDA is not bound by the committee's guidance. The drug had previously received Breakthrough Therapy Designation from the FDA for this setting.

Regulatory applications for camizestrant in this setting are also under review in the EU, Japan, and several other countries. The company maintains confidence in the clinical benefit the combination can offer patients.