Xtandi (enzalutamide)
- Region
- 🇪🇺 EU
- Active substance
- enzalutamide
- Company
- Astellas Pharma Europe B.V.
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 25 Apr 2013
- EU approval
- Fri 21 Jun 2013
- Application
- EMEA/H/C/002639
- ATC
- L02BB04
- Official record
- www.ema.europa.eu
Indication
Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Enzalutamide Viatris Authorised · Viatris Limited
- 🇪🇺 Enzalutamide Accordpharma Authorised · Accord Healthcare
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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.