Regulatory approval

Published by the Health Canada.

Health Canada approved inavolisib in combination with palbociclib and fulvestrant 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 as:

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.

Citation

Hoffmann-La Roche Limited. Itovebi (inavolisib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078611.PDF. Published February 2025. Accessed June 2025.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative, PIK3CA somatic variants	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
Sensitivity (+)	HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
Sensitivity (+)	ER positive, HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib