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Enfortumab vedotin
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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Enfortumab vedotin is a type of targeted therapy called an antibody-drug conjugate. Antibody-drug conjugates consist of a monoclonal antibody chemically linked to a drug. The monoclonal antibody part of enfortumab vedotin binds to a protein called nectin-4, which is found on the surface of most bladder cancer cells. The antibody is chemically linked to monomethyl auristatin E, or MMAE, a type of chemotherapy drug called a microtubule inhibitor. Once the conjugate is taken up by cells, the drug stops them from dividing and leads to their death.
The FDA approved enfortumab vedotin for patients with metastatic urothelial carcinoma that has progressed after treatment with both platinum-based first-line chemotherapy and second-line therapy with an immune checkpoint inhibitor. The approval was based on a single-arm trial of 125 patients with metastatic urothelial carcinoma.[54]
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Evidence (enfortumab vedotin):
In a single-arm trial, 125 patients with metastatic urothelial carcinoma were treated with enfortumab vedotin.[54]Because there was no control arm, this study could not demonstrate an improvement in OS or quality of life. A follow-up phase III trial is under way to assess the benefits of this medication.
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In a single-arm trial, 125 patients with metastatic urothelial carcinoma were treated with enfortumab vedotin.[54]Because there was no control arm, this study could not demonstrate an improvement in OS or quality of life. A follow-up phase III trial is under way to assess the benefits of this medication.
There was a 44% overall response rate and a 12% complete response rate.
In a single-arm trial, 125 patients with metastatic urothelial carcinoma were treated with enfortumab vedotin.[54]Because there was no control arm, this study could not demonstrate an improvement in OS or quality of life. A follow-up phase III trial is under way to assess the benefits of this medication.
The median duration of response was 7.6 months.
In a single-arm trial, 125 patients with metastatic urothelial carcinoma were treated with enfortumab vedotin.[54]Because there was no control arm, this study could not demonstrate an improvement in OS or quality of life. A follow-up phase III trial is under way to assess the benefits of this medication.
Adverse events included fatigue (50%), peripheral neuropathy (50%), alopecia (49%), rash (48%), decreased appetite (44%), and dysgeusia (40%).
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