New filings for Padcev in bladder cancer

Japanese drugmaker Astellas (TYO: 4503) and US biotech Seagen (Nasdaq:SGEN) have submitted two supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv).

One submission, based on the Phase III EV-301 trial, seeks to convert Padcev’s accelerated approval to regular approval. The second, based on the pivotal trial EV-201’s second cohort, requests an expansion of the current label to include patients with locally-advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

"Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options"The FDA is reviewing both applications under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.