The FDA granted accelerated approval to AstraZeneca’s oral SERD camizestrant (Camizestrant) combined with a CDK4/6 inhibitor for patients with emergent ESR1-mutated HR+, HER2– advanced breast cancer, even after an adverse advisory committee vote earlier this year. The decision keeps the focus on the ESR1 resistance axis in hormone receptor–positive disease. The accelerated approval mechanism reflects the agency’s reliance on available efficacy data while continuing to require confirmatory evidence for the broader lifecycle of approval. For AstraZeneca, the move provides a near-term path for oral SERD positioning alongside existing SERD and CDK4/6 strategies. For clinicians, the approval expands treatment options for patients with ESR1-mutated tumors that emerge during prior endocrine therapy, a subgroup where sequencing decisions are particularly consequential.