AstraZeneca won an FDA accelerated approval for camizestrant, trading under the Etcamah brand, after an advisory committee previously voted against the drug’s first-line breast cancer use. The approval supports HR+/HER2− advanced breast cancer with detected ESR1 mutations during aromatase inhibitor and CDK4/6 inhibitor therapy. The decision also includes Guardant Health’s Guardant360 companion diagnostic to identify ESR1 mutations, enabling earlier treatment switches than prior standards that typically required radiographic progression. With the FDA rejecting the broader paradigm question earlier in the year, the approval underscores regulators’ willingness to accept progression-free survival signals in narrowly defined biomarker-positive populations.