Basic Information
Truqap
Regulatory Information
EMEA/H/C/006017
June 17, 2024
April 25, 2024
1
July 11, 2024
Company Information
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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 practice standards should be considered.
Overview Summary
Truqap is a cancer medicine used in adults to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body) when the cancer has come back or worsened after hormonal treatment. It is used when the cancer cells have receptors (targets) for certain hormones on their surface (ER-positive) and do not have large quantities of another receptor called HER2 (HER2-negative). The cancer cells must also have been shown to have one or more mutations (changes) in the PIK3CA, AKT1 or PTEN genes. Truqap is used in combination with fulvestrant (an anti-oestrogen medicine). If Truqap is used in women before the menopause or around the time of menopause (pre-menopausal or peri-menopausal), it should also be given in combination with a luteinising hormone-releasing hormone (LHRH) agonist (a medicine that lowers blood levels of the hormones oestrogen and progesterone). Truqap contains the active substance capivasertib.