Quick answers
- What is Enfortumab vedotin used for?
- The FDA-approved label (Padcev Ejfv, Seagen Inc., August 4, 2026) says: “PADCEV ®, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Enfortumab vedotin have a boxed warning?
- Yes. The FDA label for Padcev Ejfv has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Enfortumab vedotin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Enfortumab vedotin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Enfortumab vedotin?
- 1 company lists prescription products of Enfortumab vedotin in the FDA NDC Directory, including Seagen Inc..
What Enfortumab vedotin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PADCEV ®, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). …
— FDA label: Padcev Ejfv, Seagen Inc., effective August 4, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Padcev Ejfv |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Seagen Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761137 PADCEV | Astellas | December 18, 2019 | 12, latest July 10, 2026 2026: Efficacy · 2025: Efficacy · 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2268311, 2268315, 2268317, 2268319 |
|---|---|
| SPL set ID of the quoted label | b5631d3e-4604-4363-8f20-11dfc5a4a8ed |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761137 |
| Active ingredients (FDA) | ENFORTUMAB VEDOTIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Padcev Ejfv, Seagen Inc., effective August 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →