Padcev (enfortumab vedotin)
- Region
- 🇪🇺 EU
- Active substance
- enfortumab vedotin
- Company
- Astellas Pharma Europe B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Transitional Cell; Urologic Neoplasms
- CHMP opinion
- Thu 24 Feb 2022
- EU approval
- Wed 13 Apr 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005392
- ATC
- L01FX13
- Official record
- www.ema.europa.eu
Indication
Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC). Unresectable or metastatic urothelial cancer Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. Locally advanced or metastatic urothelial cancer Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor‑1 or programmed death‑ligand 1 inhibitor (see section 5.1).
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.