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Treats muscle invasive bladder cancer (MIBC). Sold as Padcev. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Enfortumab Vedotin-Ejfv (sold as Padcev), first approved Dec 18, 2019, with 7 new uses approved and 0 published complete response letters.
First approved: Dec 18, 2019
Applications: 1
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $743M
First approved in the EU: Apr 13, 2022
First approved in Japan: Sep 27, 2021
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 21 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
PadcevDrugs with a new indication and a new dosage for the treatment of unresectable urothelial carcinoma. · Astellas Pharma Inc. · Sep 24, 2024
Padcev, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable urothelial carcinoma that has progressed after cancer chemotherapy. · Astellas Pharma Inc. · Sep 27, 2021
Clinical Trials
12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astellas