PIK3CA
3 EU-approved indications of 3 drugs need a PIK3CA result, in 1 tumour type, most of them in breast cancer.
Approved indications3
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Breast cancer3 | ||||
Piqray | HR-positive, HER2-negative | + fulvestrant | 2L advanced | Following an endocrine-based regimen; Postmenopausal women, and men |
Truqap | 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 |
Itovebi | ER-positive, HER2-negative | + palbociclib and fulvestrant | 2L advanced | After adjuvant endocrine treatment with recurrence on or within 12 months of completion (if previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting, an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and detection of recurrence is required); In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist |
PIK3CA by tumour
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Alpelisib (Piqray)
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).
- Inavolisib (Itovebi)
Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1).
- 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).