Regulatory approval

Published by the Health Canada. Approved

PIQRAY (alpelisib), in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Canada Inc. Piqray (alpelisib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082186.PDF. Revised October 2025. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	ER positive, HER2-negative, PIK3CA oncogenic variants	Invasive Breast Carcinoma	Alpelisib, Fulvestrant
HC (1)	HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Alpelisib, Fulvestrant
HC (1)	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