Accelerated approval to Padcev for urothelial cancer

February 6, 2020 0 By FM

The US FDA granted accelerated approval to Padcev for the treatment of adult patients with locally advanced or metastatic urothelial cancer, Astellas Pharma and Seattle Genetics announced.

Padcev is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.

Padcev was evaluated in the pivotal trial EV-201, a single-arm phase 2 multi-centre 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.

In the study, the primary endpoint of confirmed objective response rate (ORR) was 44 percent per blinded independent central review (55/125; 95% Confidence Interval [CI]: 35.1, 53.2). Among patients treated with the single agent Padcev, 12 percent (15/125) experienced a complete response, meaning no cancer could be detected at the time of assessment, and 32 percent (40/125) experienced a partial response, meaning a decrease in tumour size or the extent of cancer in the body.