Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.