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US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA / AKT1 / PTEN Alterations.

Asma DilawariJames ButurlaChristy OsgoodXin GaoWei ChenTiffany K RicksTimothy SchaeferSreedevi AvasaralaFrancisca Reyes TurcuAnand PathakShyam KalavarVishal BhatnagarJustin S CollazoNam Atiqur RahmanBronwyn D MixterShenghui TangRichard PazdurPaul KluetzLaleh Amiri-Kordestani
Published in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2024)
alterations. Benefit-risk assessment in this subgroup was favorable based on a statistically significant and clinically meaningful improvement in PFS in the context of an acceptable safety profile including no evidence of a potential detriment in overall survival. By contrast, the benefit-risk was unfavorable in the biomarker-negative population.
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