Regulatory approval

Published by the Health Canada.

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/00078178.PDF. Revised January 2025. Accessed June 2025.

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Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) HER2-negative, PIK3CA somatic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) ER positive, HER2-negative, PIK3CA somatic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 somatic variants, ER positive, HER2-negative Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 somatic variants, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
HC (1) AKT1 somatic 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