Regulatory approval

Published by the Health Canada. Approved

ITOVEBI (inavolisib film-coated tablets), in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.

This is written in the approval document.

Citation

Hoffmann-La Roche Limited. Itovebi (inavolisib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00081926.PDF. Published 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	Fulvestrant, Inavolisib, Palbociclib
HC (1)	HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
HC (1)	ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals