enfortumab vedotin
Enfortumab vedotin (Padcev) is an antibody-drug conjugate that targets Nectin-4, a protein found on bladder cancer cells. It delivers a cancer-killing drug directly to those cells. It is used alone or with pembrolizumab to treat certain types of bladder and urinary tract cancers.
This page is based on EMA and FDA prescribing information for enfortumab vedotin injection, cross-checked with DailyMed; the mechanism is explained in plain language, and analogies are used only where they stay accurate.
How it works
Explains what the medicine does in the body, not dosing, side effects, or safety.
An analogy
Enfortumab vedotin is like a guided missile. The antibody part homes in on Nectin-4, a protein found on the surface of bladder cancer cells. Once it docks onto the cell, the cancer-killing drug attached to it is released inside, destroying the cancer cell from within while sparing most healthy cells that don't carry Nectin-4.
In simple terms
Enfortumab vedotin is made of two parts: an antibody that finds bladder cancer cells, and a cancer-killing drug attached to it. The antibody binds to a protein called Nectin-4, which is found in large amounts on the surface of bladder cancer cells. Once the antibody attaches to the cancer cell, the cell pulls the whole molecule inside, and the cancer-killing drug is released, destroying the cell. This targeted approach helps limit damage to healthy cells. It is used to treat certain types of bladder and urinary tract cancers, either alone or together with pembrolizumab (an immunotherapy).
In depth
Enfortumab vedotin is a first-in-class antibody-drug conjugate (ADC) consisting of a human IgG1 monoclonal antibody directed against Nectin-4, conjugated to monomethyl auristatin E (MMAE), a microtubule-disrupting agent. Nectin-4 is overexpressed in urothelial carcinoma and other tumors. Upon binding to cell-surface Nectin-4, the ADC is internalized, and MMAE is released by proteolytic cleavage. MMAE binds to tubulin, disrupting microtubule networks, inducing G2/M cell cycle arrest, and triggering apoptosis. The ADC also exhibits bystander effects, as membrane-permeable MMAE can kill neighboring cells regardless of Nectin-4 expression. Enfortumab vedotin is used as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial cancer and as perioperative treatment for muscle-invasive bladder cancer.
See it in motion
A schematic animation of the mechanism — simplified for clarity, not drawn to scale.
Enfortumab vedotin is like a guided missile.
- Enfortumab vedotin is made of two parts: an antibody that finds bladder cancer cells, and a cancer-killing drug attached to it.
- The antibody binds to a protein called Nectin-4, which is found in large amounts on the surface of bladder cancer cells.
- Once the antibody attaches to the cancer cell, the cell pulls the whole molecule inside, and the cancer-killing drug is released, destroying the cell.
- This targeted approach helps limit damage to healthy cells.
Target: Nectin-4
A cell-surface adhesion protein overexpressed on urothelial cancer cells; serves as the binding target for enfortumab vedotin, enabling selective delivery of the cytotoxic payload to tumor cells.
Approved uses
Approved uses differ by country and change over time. Always follow your local prescribing information.
Approved uses in European Union
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
Approved uses in United States
FDA- PADCEV, in combination with pembrolizumab, 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)
- PADCEV, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC)
- PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy
Approved uses in United States
DailyMed- PADCEV, in combination with pembrolizumab, 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)
- PADCEV, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC)
- PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy
Official sources
The statements on this page trace back to these records.
- U.S. Food and Drug Administration: enfortumab vedotin prescribing information
U.S. Food and Drug Administration
- DailyMed: enfortumab vedotin labeling
DailyMed, U.S. National Library of Medicine
This page explains how the medicine works — it isn’t the patient leaflet. For anything that applies to you, read the leaflet that came with your medicine or ask your pharmacist.
MedUnfold provides educational content and is not medical advice. Always follow your local prescribing information and healthcare professional.