FDA approves AstraZeneca breast-cancer pill despite panel’s no

The FDA has granted accelerated approval to AstraZeneca’s camizestrant, to be sold as Etcamah, for a narrow group of patients with advanced breast cancer that is driven by hormones and lacks the HER2 target. The pill is for patients whose tumors develop an ESR1 mutation, a change that can help cancer evade hormone treatment, while they are still on their first treatment; it replaces one hormone drug while they continue a separate medicine that slows cancer-cell division. The decision stands out because an FDA advisory panel voted 6–3 against the drug in April, questioning whether acting on a mutation found in a blood test before scans show tumor growth delivers a meaningful long-term benefit. The FDA is not bound by that advice, but the accelerated approval means AstraZeneca will still need further evidence to confirm the treatment’s benefit.