AKT1/PIK3CA/PTEN

1 EU-approved indication of 1 drug needs a AKT1/PIK3CA/PTEN result, in 1 tumour type, most of them in breast cancer.

Approved indications1

DrugBiomarker requirementRegimenSettingConditions
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

AKT1/PIK3CA/PTEN by tumour

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Capivasertib (Truqap)
    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).