Truqap (capivasertib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication

Statements

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	AKT1 somatic variants, ER positive, HER2-negative	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	AKT1 amplification, ER positive, HER2-negative	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PIK3CA somatic variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
Sensitivity (+)	ER positive, HER2-negative, PIK3CA amplification	Invasive Breast Carcinoma	Capivasertib, Fulvestrant