With a vote of three to six, the FDA's Oncologic Drugs Advisory Committee (ODAC) failed to reach a majority vote in favor of the benefit–risk profile of AstraZeneca's camizestrant, an oral drug to treat breast cancer.
AstraZeneca is proposing camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor, either palbociclib, ribociclib, or abemaciclib. It would be a first-line treatment for hormone-receptor (HR)-positive, HER2-negative advanced breast cancer where tumors have an emergent ESR1 mutation.
The vote follows the FDA’s acceptance of the NDA for camizestrant in combination with a CDK4/6 inhibitor back in July 2025. This was based on the SERENA-6 phase 3 trail, which showed a statistically-significant 56% reduction in disease progression or death compared to a combination of aromatase inhibitor (either anastrozole or letrozole) and CDK4/6 inhibitor. The drug combinations also had a safety profile consistent with that of the individual CDK4/6 inhibitors.
Since the outcome from the ODAC is only guidance, the FDA is not bound to take any particular course of action. AstraZeneca has said it will continue to work with the FDA as the agency completes its review of the application.