Enfortumab vedotin comment watch save
Breastfeeding

  • TRADE NAME: Padcev (Astellas)
  • INDICATIONS:

    Treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

    Approved under accelerated approval based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. 


  • CLASS: Antibody-drug conjugate (ADC), Biologic, Microtubule inhibitor, Monoclonal antibody
  • HALF-LIFE: 3.4 days (monoclonal antibody moiety); 2.4 days (monomethyl auristatin E moiety)
  • FDA APPROVAL DATE: 12/18/2019
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    CYP3A4 inhibitors

Enfortumab vedotin is an anti-Nectin-4 IgG1 kappa monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E via a protease-cleavable maleimidocaproyl valine-citrulline linker.

Enfortumab vedotin-ejfv is biosimilar

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Page last updated 09/04/2025

Symbol key

Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric