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Enfortumab
Enfortumab is a Small molecule drug developed by Brigham and Women's Hospital. It is currently in Phase 1 development for Metastatic urothelial carcinoma.
Enfortumab vedotin is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate, specifically targeting urothelial carcinoma conditions such as Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, and Metastatic Urothelial Carcinoma.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 |
|---|---|
| Sponsor | Brigham and Women's Hospital |
| Target | Nectin-4, Tubulin beta |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Approved indications
- Metastatic urothelial carcinoma
Common side effects
Key clinical trials
- A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma ( (Phase 1)
- A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer (Phase 2)
- A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS-22M6E or ASG-22CE Given as Monotherapy Followed by Expansion Cohorts in Subjects With Malignant Solid Tumors That Express (Phase 1)
- International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced/Metastatic Urothelial Cancer (ARON-2PLUS) (N/A)
- Circulating Tumor DNA Response Adapted Treatment De-escalation Metastatic Urothelial Carcinoma (CT-READ) (Phase 2)
- FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated (Phase 3)
- A Randomized, Open-Label, Controlled, Multicenter Phase 2 Trial of SYS6002 Versus PADCEV in Patients With Advanced Urothelial Carcinoma (Phase 2)
- Phase II Trial of Enfortumab Vedotin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma (Phase 2)
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 CI brief — competitive landscape report
- Enfortumab updates RSS · CI watch RSS
- Brigham and Women's Hospital portfolio CI
Frequently asked questions about Enfortumab
What is Enfortumab?
What is Enfortumab used for?
Who makes Enfortumab?
What development phase is Enfortumab in?
What does Enfortumab target?
Related
- Target: All drugs targeting Nectin-4, Tubulin beta
- Manufacturer: Brigham and Women's Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic urothelial carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing