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-KordestaniPublished 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.
Keyphrases
- metastatic breast cancer
- epidermal growth factor receptor
- drug administration
- human health
- risk assessment
- locally advanced
- tyrosine kinase
- advanced non small cell lung cancer
- cell proliferation
- endothelial cells
- squamous cell carcinoma
- rectal cancer
- neoadjuvant chemotherapy
- magnetic resonance
- signaling pathway
- pluripotent stem cells
- induced pluripotent stem cells
- heavy metals
- radiation therapy
- climate change
- computed tomography
- protein kinase
- open label