The U.S. FDA has granted Seagen and Astellas' co-developed bladder cancer treatment, Padcev, regular approval plus approval for a new indication, making the drug the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer.
Two years ago, Washington-based Seagen and Tokyo-based were granted a conditional, accelerated FDA approval to target urothelial cancer. FDA's accelerated approval regulations allow drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint.
The FDA’s decision to convert, Padcev's accelerated approval to regular approval was based on data from the phase 3 EV-301 trial, which had a primary endpoint of overall survival for patients treated with Padcev versus chemotherapy The conversion from accelerated approval to regular approval and the label expansion were based on two supplemental Biologics License Applications reviewed under the Real-Time Oncology Review (RTOR) pilot program.
The label expansion allows for the use of Padcev to treat patients with advanced or metastatic urothelial cancer who aren’t eligible for cisplatin chemo. These cisplatin-ineligible patients typically have limited treatment options and a poor prognosis.
Read the press release.
