Capivasertib
Capivasertib (Truqap, AstraZeneca AB) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: AKT1/PIK3CA/PTEN (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer1 | |||
One or more PIK3CA/AKT1/PTEN-alterations, ER-positive, HER2-negative | + fulvestrant | 2L 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 |
Full text of section 4.1 (therapeutic indications)
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). 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 practice standards should be considered.
Label history
5 changes to the Truqap label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes