Enfortumab vedotin
Enfortumab vedotin is an antibody-drug conjugate designed for the treatment of cancer expressing Nectin-4. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug and the linker.
The most common side effects are fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritis and dry skin.
The fully humanized antibody was created by scientists at Agensys using Xenomice from Amgen; the linker technology holding the antibody and the toxin together was provided by and licensed from Seattle Genetics.
Results of a Phase I clinical trial were reported in 2016.Approvals
In December 2019, enfortumab vedotin-ejfv was approved in the United States for the treatment of adult patients with locally advanced or metastatic urothelial cancer who had previously received a programmed cell death receptor-1 or programmed death ligand 1 inhibitor and a platinum-containing chemotherapy.
Enfortumab vedotin was approved based on the results of a clinical trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. The overall response rate, reflecting the percentage of patients who had a certain amount of tumor shrinkage, was 44%, with 12% having a complete response and 32% having a partial response. The median duration of response was 7.6 months.
The application for enfortumab vedotin-ejfv was granted accelerated approval, priority review designation, and breakthrough therapy designation. The U.S. Food and Drug Administration granted the approval of Padcev to Astellas Pharma US Inc.
