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ENFORTUMAB VEDOTIN
Enfortumab vedotin-ejfv binds to Nectin-4 on cancer cells, internalizes, releases MMAE, disrupting microtubules and causing cell death.
At a glance
| Generic name | ENFORTUMAB VEDOTIN |
|---|---|
| Target | Nectin-4 |
| Modality | Antibody drug conjugate |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
Enfortumab vedotin-ejfv is an antibody-drug conjugate that targets Nectin-4, a protein found on cancer cells. Once bound, the drug is taken inside the cell where it releases MMAE, which disrupts the cell's internal structure, leading to cell death. Combining it with a PD-1 inhibitor can further enhance its effectiveness.
Approved indications
- Neoadjuvant and Adjuvant Treatment of MIBC
- Locally Advanced or Metastatic Urothelial Cancer (Combination Therapy)
- Locally Advanced or Metastatic Urothelial Cancer (Single Agent)
Boxed warnings
- WARNING: SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions. • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. • PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ), ( 6.1 )
Common side effects
- Rash
- Peripheral neuropathy
- Fatigue
- Alopecia
- Decreased appetite
- Hemoglobin decreased
- Diarrhea
- Nausea
- Pruritus
- Dysgeusia
- Alanine aminotransferase increased
- Anemia
Drug interactions
- dual P-gp and strong CYP3A4 inhibitors
Key clinical trials
- Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy (PHASE1)
- Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) (PHASE2)
- A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (PHASE1, PHASE2)
- FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3 (PHASE1)
- 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)
- A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma (PHASE2)
- A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
- Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer (PHASE1)
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 VEDOTIN CI brief — competitive landscape report
- ENFORTUMAB VEDOTIN updates RSS · CI watch RSS