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Enfortumab (padcev)
Enfortumab (padcev) is a small molecule drug developed by Astellas, targeting Nectin-4. It was FDA-approved in 2019 for the treatment of metastatic urothelial carcinoma. Enfortumab is a patented medication with a half-life of approximately 3.6 days. Key safety considerations include potential side effects such as fatigue, nausea, and skin reactions. As a relatively new medication, its long-term safety profile is still being evaluated.
At a glance
| Generic name | padcev |
|---|---|
| Sponsor | Astellas Pharma |
| Target | Nectin-4 |
| Modality | ADC |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
- Metastatic urothelial carcinoma
Common side effects
- Alopecia
- Decreased appetite
- Diarrhoea
- Fatigue
- Pruritus
- Nausea
- Peripheral sensory neuropathy
- Constipation
- Anaemia
- Dysgeusia
- Pyrexia
- Rash
Key clinical trials
- A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (PHASE3)
- A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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
- Astellas Pharma portfolio CI