Is Enfortumab vedotin approved by the US FDA?

Drugs@FDA lists 1 application product line for Enfortumab vedotin, including PADCEV (Prescription).

Is Enfortumab vedotin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Enfortumab vedotin: Padcev.

Are there safety signals or safety updates for Enfortumab vedotin?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-07-10).

Active substance

Enfortumab vedotin

US FDA 1
EMA 1
Health Canada 2
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PADCEV	20MG/VIAL; 30MG/VIAL	injectable · injection	ASTELLAS	Prescription	18 Dec 2019

EMA European Union — centrally authorised medicines

Padcev Astellas Pharma Europe B.V. · Authorised · authorised 13 Apr 2022 · ATC L01FX13

Therapeutic indication (EMA)

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).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PADCEV	02521903	20 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
PADCEV	02521911	30 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 10 Jul 2026 PADCEV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2022 PRAC signal: Interstitial lung disease (ILD)
Action for MAH: update of the product information: No

All safety entries for enfortumab vedotin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.