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Padcev Ejfv (enfortumab-vedotin)
Padcev Ejfv (generic name: enfortumab-vedotin) is a Monoclonal antibody drug developed by Astellas Pharma. It is currently FDA-approved (first approved 2019).
Enfortumab vedotin-ejfv binds to Nectin-4, internalizes, releases MMAE, disrupting microtubules and causing cell death.
Enfortumab vedotin, also known as Padcev, is a small molecule antibody-drug conjugate developed by Astellas. It is used to treat certain types of bladder and lung cancers. Padcev works by targeting a protein on cancer cells and delivering a toxic payload to kill the cells. It is a patented medication and its commercial status is not off-patent. Key safety considerations include neutropenia, anemia, and fatigue.
At a glance
| Generic name | enfortumab-vedotin |
|---|---|
| Sponsor | Astellas Pharma |
| Target | Nectin-4 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
Enfortumab vedotin-ejfv is an antibody-drug conjugate that targets Nectin-4 on cancer cells. Once bound, it is internalized and releases MMAE, which disrupts microtubules, leading to cell cycle arrest and apoptosis. Combining it with a PD-1 blocker enhances immune response and anti-tumor activity.
Approved indications
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
- Increased glucose
- Increased aspartate aminotransferase
- Decreased hemoglobin
- Rash
- Increased creatinine
- Peripheral neuropathy
- Increased alanine aminotransferase
- Fatigue
- Decreased lymphocytes
- Decreased albumin
- Pruritus
- Decreased sodium
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:
- Padcev Ejfv CI brief — competitive landscape report
- Padcev Ejfv updates RSS · CI watch RSS
- Astellas Pharma portfolio CI
Frequently asked questions about Padcev Ejfv
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Related
- Target: All drugs targeting Nectin-4
- Manufacturer: Astellas Pharma — full pipeline
- Therapeutic area: All drugs in Oncology
- Compare: Padcev Ejfv vs similar drugs
- Pricing: Padcev Ejfv cost, discount & access