Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized capivasertib in combination with fulvestrant for the treatment of adult patients with estrogen 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. Capivasertib's product information further states that in pre- or perimenopausal women, capivasertib plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. The product information further states that, for men, administration of LHRH agonist according to current clinical practices should be considered. This indication is based on CAPItello-291, a randomized, double-blind, placebo-controlled trial, where HER2-negative status was defined as either IHC 0 or 1+, or IHC 2+/ISH-, and qualifying alterations were activating mutations in PIK3CA and AKT1 and inactivating mutations in PTEN.
This is written in the approval document as:
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. 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 practices should be considered.
Citation
AstraZeneca AB. Truqap (capivasertib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf. Revised July 2024. Accessed October 18, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ER positive, HER2-negative, PIK3CA somatic variants | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PIK3CA amplification | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | AKT1 amplification, ER positive, HER2-negative | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | AKT1 somatic variants, ER positive, HER2-negative | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PTEN nonsense variants | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PTEN frameshift variants | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PTEN splice site variants | Invasive Breast Carcinoma | Capivasertib, Fulvestrant | |
| Sensitivity (+) | ER positive, HER2-negative, PTEN deletion | Invasive Breast Carcinoma | Capivasertib, Fulvestrant |