# Capivasertib

Capivasertib (Truqap, AstraZeneca AB) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: AKT1/PIK3CA/PTEN (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| One or more PIK3CA/AKT1/PTEN-alterations, ER-positive, HER2-negative | + fulvestrant | 2nd line, advanced | Recurrence or progression on or after an endocrine-based regimen; In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a LHRH agonist; for men, administration of LHRH agonist according to current clinical practice standards should be considered |

## Products

### Truqap

- Company: AstraZeneca AB
- Target: Pan-AKT inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX27
- EU approval: 17 Jun 2024
- Label revised: 6 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/truqap-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/truqap

Mechanism (SmPC section 5.1): Capivasertib selectively inhibits the kinase activity of all three AKT isoforms (AKT1, AKT2, AKT3), inhibiting downstream signalling involved in tumour cell survival and proliferation.

## Label wording

- **Capivasertib** (Truqap), Breast cancer, 2nd line, advanced: “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 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/capivasertib