Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative, PIK3CA oncogenic variants	Invasive Breast Carcinoma	Alpelisib, Fulvestrant
FDA (2)	HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Alpelisib, Fulvestrant
FDA (2)	ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Alpelisib, Fulvestrant

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-01-18	Food and Drug Administration	Indication received traditional approval.