Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to alpelisib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test, following progression on or after an endocrine-based regimen.
This is written in the approval document as:
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Citation
Novartis Pharmaceuticals Corporation. Piqray (alpelisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212526s009lbl.pdf. Revised January 2024. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ER positive, HER2-negative, PIK3CA somatic variants | Invasive Breast Carcinoma | Alpelisib, Fulvestrant | |
| Sensitivity (+) | HER2-negative, PIK3CA somatic variants, PR positive | Invasive Breast Carcinoma | Alpelisib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PIK3CA somatic variants, PR positive | Invasive Breast Carcinoma | Alpelisib, Fulvestrant |