[5] The most common side effects include fatigue, peripheral neuropathy (nerve damage resulting in tingling or numbness), decreased appetite, rash, alopecia (hair loss), nausea, altered taste, diarrhea, dry eye, pruritus (itching) and dry skin.

[6] 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 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.

[7][10] 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.

[7] The FDA granted the approval of Padcev to Astellas Pharma US Inc.[7] In July 2021, the FDA approved enfortumab vedotin for adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or; are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

[12] The applicant for this medicinal product is Astellas Pharma Europe B.V.[12] Enfortumab vedotin was approved for medical use in the European Union in April 2022.