On Dec. 18, 2019, Seagen and Astellas Pharma announced the U.S. Food and Drug Administration (FDA) had granted accelerated approval to PADCEV for treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.

PADCEV was approved under the FDA’s Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. PADCEV was the first FDA approved treatment in the U.S. for these patients. It is a first-in-class antibody-drug conjugate that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.