Padcev - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

enfortumab vedotin

Opinion

On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Padcev. The marketing authorisation holder for this medicinal product is Astellas Pharma Europe B.V.

The CHMP adopted a new indication as follows:

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) who are ineligible for cisplatin-containing chemotherapy.

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).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

CHMP post-authorisation summary of positive opinion for Padcev (VR-0000312495)

Adopted Reference Number: EMADOC-1700519818-3134776

Key facts

• Name of medicine:
  Padcev
• EMA product number:
  EMEA/H/C/005392
• Active substance:
  Enfortumab vedotin
• International non-proprietary name (INN) or common name:
  enfortumab vedotin
• Therapeutic area (MeSH):
  • Carcinoma, Transitional Cell
  • Urologic Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L01FX13
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Astellas Pharma Europe B.V.
• Date of opinion:
  21/05/2026
• Status:
  Positive