AKT1/PIK3CA/PTEN in breast cancer

1 EU-approved indication in breast cancer needs a AKT1/PIK3CA/PTEN result: capivasertib (2nd line, advanced).

Line of therapy

Approved indications, Breast cancer
DrugBiomarker requirementRegimenSettingConditions
AKT1/PIK3CA/PTEN alteration1
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

See also

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).