Regulatory approval

Published by the Health Canada. Approved

Health Canada approved capivasertib, in combination with fulvestrant, for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

This is written in the approval document as:

TRUQAP (capivasertib tablets), in combination with fulvestrant, is indicated for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Citation

AstraZeneca Canada Inc. Truqap (capivasertib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082228.PDF. Revised October 2025. Accessed April 2026.

View API

Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
HC (1) HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 oncogenic variants, ER positive, HER2-negative Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 oncogenic variants, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 oncogenic variants, ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 amplification, ER positive, HER2-negative Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 amplification, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 amplification, ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PTEN nonsense variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) HER2-negative, PR positive, PTEN nonsense variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PR positive, PTEN nonsense variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PTEN frameshift variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) HER2-negative, PR positive, PTEN frameshift variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PR positive, PTEN frameshift variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PTEN splice site variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) HER2-negative, PR positive, PTEN splice site variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PR positive, PTEN splice site variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PTEN deletion Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) HER2-negative, PR positive, PTEN deletion Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PR positive, PTEN deletion Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PIK3CA amplification Invasive Breast Carcinoma Capivasertib, Fulvestrant

Contributions

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