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enfortumab vedotin (EV)
enfortumab vedotin (EV) is a Monoclonal antibody-drug conjugate Small molecule drug developed by Astellas Pharma Global Development, Inc.. It is currently in Phase 3 development for Locally advanced or metastatic urothelial cancer, Locally advanced or metastatic non-small cell lung cancer. Also known as: ASG-22CE, Padcev, ASG-22ME, PADCEV.
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.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Frequently asked questions about enfortumab vedotin (EV)
What is enfortumab vedotin (EV)?
How does enfortumab vedotin (EV) work?
What is enfortumab vedotin (EV) used for?
Who makes enfortumab vedotin (EV)?
Is enfortumab vedotin (EV) also known as anything else?
What drug class is enfortumab vedotin (EV) in?
What development phase is enfortumab vedotin (EV) in?
What are the side effects of enfortumab vedotin (EV)?
What does enfortumab vedotin (EV) target?
Related
- Drug class: All Monoclonal antibody-drug conjugate drugs
- Target: All drugs targeting Nectin-4
- Manufacturer: Astellas Pharma Global Development, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Locally advanced or metastatic urothelial cancer
- Indication: Drugs for Locally advanced or metastatic non-small cell lung cancer
- Also known as: ASG-22CE, Padcev, ASG-22ME, PADCEV, Enfortumab Vedotin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing