Enfortumab vedotin
Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug and the linker.
The most common side effects include fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritus 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.
The U.S. Food and Drug Administration considers it to be a first-in-class medication.
Medical uses
Enfortumab vedotin is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death ligand 1 inhibitor and a platinum-containing chemotherapy.History
Results of a Phase I clinical trial were reported in 2016.In December 2019, enfortumab vedotin 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. The approval was based on the results of a clinical trial of 125 such patients. The overall response rate, reflecting the percentage of patients who had a certain amount of tumor shrinkage, was 44%; specifically, 12% had a complete response and 32% a partial response. The median duration of response was 7.6 months.
The U.S. Food and Drug Administration granted the application for enfortumab vedotin accelerated approval, priority review designation, and breakthrough therapy designation. The FDA granted the approval of Padcev to Astellas Pharma US Inc.
In July 2021, the FDA approved enfortumab vedotin for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received therapy.