The FDA granted AstraZeneca an accelerated approval for camizestrant, an oral selective estrogen receptor degrader (SERD), for patients with emergent ESR1-mutated HR+, HER2– advanced breast cancer. The decision followed a negative vote from an FDA advisory committee earlier this year. Camizestrant is positioned for a setting where ESR1 mutations drive resistance to endocrine therapies. The approval route suggests the agency accepted the clinical evidence sufficient for accelerated pathways while further follow-up is expected. The outcome tightens competitive dynamics in the oral SERD market and signals the FDA’s willingness to move despite panel disagreement when the dataset supports regulatory standards under accelerated approval.