FDA has granted accelerated approval for AstraZeneca’s oral SERD camizestrant in a defined population of ESR1-mutated HR+, HER2– advanced breast cancer, despite a negative vote from the agency’s advisory committee earlier this year. The decision keeps the focus on ESR1-driven resistance biology and expands the oral-targeted SERD toolbox for HR+ disease. The approval followed the April adcomm outcome, underscoring how FDA can act on evolving benefit-risk evidence even when outside experts express reservations. Clinicians will now align patient selection and sequencing decisions around camizestrant’s specific label criteria. For the wider SERD class, the move also highlights the ongoing regulatory willingness to consider durable endocrine pathway control in resistant, mutation-defined settings, particularly where oral administration may improve practicality versus earlier-generation approaches.