Postmarketing Cases of Enfortumab Vedotin–Associated Skin Reactions Reported as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis
Review found 8 cases of serious skin reactions characterised by the reporters as Stevens-Johnson Syndrome and toxic epidermal necrolysis from the FDA Adverse Event Reporting System. Skin toxic effects may be related to the inhibitory effects on nectin-4 expression
Source:
JAMA Dermatology
SPS commentary:
Enfortumab vedotin is a monoclonal antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent. In 2021 the European Medicines Agency accepted a marketing authorisation application for accelerated assessment. It is approved by FDA for locally advanced or metastatic urothelial cancer - third-line in patients previously treated with a PD-1/L1 inhibitor and a platinum-containing chemotherapy.