FDA ODAC VOTE ON CAMIZESTRANT IN BREAST CANCER

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The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against a majority favoring the benefit-risk profile of AstraZeneca's camizestrant combined with a CDK4/6 inhibitor for first-line treatment of HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutations, based on the SERENA-6 Phase III trial. The trial showed a 56% reduction in risk of disease progression or death (HR 0.44). The FDA is not bound by the vote. AstraZeneca expressed disappointment but remains confident in the clinical benefit and will continue working with the FDA.