Padcev
What Padcev is used for
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).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Padcev
- Active substance
- enfortumab vedotin
- Disease area
- Carcinoma, Transitional Cell; Urologic Neoplasms
- Medicine group
- Antineoplastic agents
- ATC code
- L01FX13
- Marketing authorisation holder
- Astellas Pharma Europe B.V.
- Authorised in the EU since
- 2022
Official information
In the USA
Same active substance: Padcev Ejfv
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Padcev used for?
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…
What is the active substance in Padcev?
Padcev contains enfortumab vedotin.
Who makes Padcev?
The EU marketing authorisation holder is Astellas Pharma Europe B.V..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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