Truqap (capivasertib)
- Region
- 🇪🇺 EU
- Active substance
- capivasertib
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 25 Apr 2024
- EU approval
- Mon 17 Jun 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006017
- ATC
- L01EX27
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.