AstraZeneca secured EU backing for camizestrant, strengthening its breast cancer portfolio even as the FDA panel questioned the trial design rather than the drug’s safety or efficacy.
The European Medicines Agency’s committee recommended approval of camizestrant in combination with CDK4/6 inhibitors for HR-positive, HER2-negative metastatic breast cancer with ESR1 mutations, based on the SERENA-6 trial.
The FDA panel voted against camizestrant approval, citing concerns about the statistical design and timing of the SERENA-6 trial despite the regimen showing improved progression-free survival.
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