US biotechnology company Seagen Inc (Nasdaq:SGEN) and Astellas Pharma Inc (TSE:4503), a pharmaceutical company based in Japan, said on Thursday that they have submitted two supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) for PADCEV (enfortumab vedotin-ejfv).

PADCEV was approved by the US Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.

One submission, based on the phase 3 EV-301 trial, seeks to convert PADCEV's accelerated approval to regular approval. The second submission, 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.

The FDA is reviewing both applications under Real-Time Oncology Review (RTOR), which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.