Astellas and Seattle Genetics announced that the FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv) for the treatment of certain adults with locally advanced or metastatic urothelial cancer. Specifically, the antibody-drug conjugate (ADC), which targets Nectin-4, is indicated for use in patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic setting.
According to the companies, Padcev is the first FDA approved treatment in the US for these patients, with the agency's decision coming around three months before the goal date. In 2011, Seattle Genetics exercised an option to co-develop the drug, formerly known as ASG-22ME, under the companies' existing ADC collaboration agreement forged in 2007.
Astellas and Seattle Genetics noted that approval of Padcev was based on results of the mid-stage EV-201 study, which 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 trial, the overall response rate was 44%, with 12% of patients having a complete response and 32% having a partial response. The median duration of response was 7.6 months.
A Phase III confirmatory trial, called EV-301, is currently being conducted by Astellas and Seattle Genetics, which is also intended to support global registrations for Padcev.
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