Talzenna (talazoparib)
- Region
- 🇪🇺 EU
- Active substance
- talazoparib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Fri 26 Apr 2019
- EU approval
- Thu 20 Jun 2019
- Application
- EMEA/H/C/004674
- ATC
- L01XK04
- Official record
- www.ema.europa.eu
Indication
Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.
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.