One Man's Meat Is Another Man's Poison: High Incidence of Severe Cutaneous Drug Reactions Induced by Enfortumab Vedotin.

ABSTRACT:

Background and objective

Enfortumab vedotin (EV), an antibody-drug conjugate targeting nectin-4 and linked to monomethyl auristatin E, has shown efficacy in metastatic urothelial carcinoma. However, emerging evidence has identified severe cutaneous adverse events (cAEs), particularly Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). To date, no comprehensive analysis of cAEs associated with EV has been reported. This study aims to investigate the incidence, onset time, and factors associated with cAEs, particularly SJS/TEN, in patients treated with EV, using data from the U.S. Food and Drug Administration's Adverse Event Reporting System.

Methods

This retrospective study analyzed data from January 1, 2020 to November 1, 2024, covering 2736 patients. A disp

SUBMITTER: Pan Y 

PROVIDER: S-EPMC12392638 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature