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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	AKT1 Somatic 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 Somatic variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
EMA (1)	ER positive, HER2-negative, PIK3CA amplification	Invasive Breast Carcinoma	Capivasertib, Fulvestrant