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 <i>PIK3CA</i> / <i>AKT1</i> / <i>PTEN</
Capivasertib with fulvestrant was approved for patients whose tumors harbored <i>PIK3CA/AKT1/</i><i>PTEN</i> 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.
Authors
- Nam Atiqur Rahman (ORCID: https://orcid.org/0009-0001-0002-7006)
- Shyam Kalavar
- Bronwyn D. Mixter (ORCID: https://orcid.org/0000-0001-5277-4399)
- Christy Osgood (ORCID: https://orcid.org/0000-0001-7450-9342)
- Shenghui Tang (ORCID: https://orcid.org/0000-0002-0437-665X)
- Richard Pazdur (ORCID: https://orcid.org/0000-0002-4771-9923)
- Paul G. Kluetz (ORCID: https://orcid.org/0000-0002-9796-4791)
- Francisca Reyes Turcu
- Laleh Amiri‐Kordestani (ORCID: https://orcid.org/0000-0002-0056-5437)
- Vishal Bhatnagar (ORCID: https://orcid.org/0000-0003-4650-0513)
- Justin S. Collazo
- Tiffany K. Ricks
- Asma Dilawari (ORCID: https://orcid.org/0000-0001-5706-9138)
- Wei Chen (ORCID: https://orcid.org/0000-0003-3213-5412)
- Timothy J. Schaefer
- Xin Gao (ORCID: https://orcid.org/0000-0002-7383-6453)
- Anand Pathak (ORCID: https://orcid.org/0000-0002-5707-5316)
- James Buturla
- Sreedevi Avasarala
Institutions
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
- Center for Devices and Radiological Health (US)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2024-08-19
- DOI
- https://doi.org/10.1200/jco.24.00427
- Citations
- 31
- Primary Topic
- Advanced Breast Cancer Therapies
- Type
- article
- Field-Weighted Citation Impact
- 12.99