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enfortumab vedotin (EV)
Enfortumab vedotin is a monoclonal antibody-drug conjugate that targets Nectin-4, a protein highly expressed on the surface of certain cancer cells.
Enfortumab vedotin is a monoclonal antibody-drug conjugate that targets Nectin-4, a protein highly expressed on the surface of certain cancer cells. Used for Locally advanced or metastatic urothelial cancer, Locally advanced or metastatic non-small cell lung cancer.
At a glance
| Generic name | enfortumab vedotin (EV) |
|---|---|
| Also known as | ASG-22CE, Padcev, ASG-22ME, PADCEV, Enfortumab Vedotin |
| Sponsor | Astellas Pharma Global Development, Inc. |
| Drug class | Monoclonal antibody-drug conjugate |
| Target | Nectin-4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to Nectin-4, enfortumab vedotin delivers a cytotoxic agent to cancer cells, leading to cell death. This targeted approach aims to minimize harm to healthy cells while maximizing the impact on cancer cells. Enfortumab vedotin has shown promise in treating certain types of cancer, including bladder and non-small cell lung cancer.
Approved indications
- Locally advanced or metastatic urothelial cancer
- Locally advanced or metastatic non-small cell lung cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Anemia
- Thrombocytopenia
- Neutropenia
- Anorexia
- Weight loss
- Hypertension
Key clinical trials
- A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (PHASE1, PHASE2)
- KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04) (PHASE1, PHASE2)
- Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer (PHASE1)
- Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma (PHASE2)
- A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract (PHASE3)
- Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (PHASE2, PHASE3)
- N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer (PHASE1)
- Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- enfortumab vedotin (EV) CI brief — competitive landscape report
- enfortumab vedotin (EV) updates RSS · CI watch RSS
- Astellas Pharma Global Development, Inc. portfolio CI