Regulatory approval

Published by the European Medicines Agency. Approved

TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practices should be considered.

This is written in the approval document.

Citation

AstraZeneca AB. Truqap (capivasertib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf. Revised July 2024. Accessed October 18, 2024.

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Therapeutic response

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

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

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2024-06-17 European Medicines Agency Indication received approval from the European Commission.