Regulatory approval

Published by the Health Canada.

Health Canada approved 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 as:

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.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)