Last reviewed 2026-04-20 · How we verify

Padcev (AGS-22M6E)

Padcev works by binding to Nectin-4 on the surface of cancer cells, marking them for destruction.

Padcev (AGS-22M6E) is a small molecule drug developed by Astellas, targeting Nectin-4. It was FDA-approved in 2019 for the treatment of metastatic urothelial carcinoma. Padcev works by binding to Nectin-4, a protein found on the surface of cancer cells, and is not yet off-patent. As a patented drug, it is not yet available as a generic. Key safety considerations include its half-life of 3.6 days.

At a glance

Mechanism of action

Enfortumab vedotin-ejfv is an ADC. The antibody is human IgG1 directed against Nectin-4, an adhesion protein located on the surface of cells. The small molecule, MMAE, is microtubule-disrupting agent, attached to the antibody via protease-cleavable linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin-ejfv is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalization of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic cell death.

Approved indications

• Metastatic urothelial carcinoma

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
• Anemia
• Albumin decreased

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)
• 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)
• A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
• A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder (PHASE2)
• A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors (PHASE1,PHASE2)
• A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Padcev CI brief — competitive landscape report
• Padcev updates RSS · CI watch RSS
• Astellas Pharma portfolio CI