Accelerated approval to Padcev for urothelial cancerFebruary 6, 2020
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.