Itovebi (inavolisib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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