Two sBLAs filed with FDA for Padcev in urothelial cancer.- Astellas Pharma + Seagen

Astellas Pharma and Seagen have filed two supplemental Biologics License Application (sBLA) submissions with the FDA for Padcev (enfortumab vedotin-ejfv) for review as part of the Real-Time Oncology Review (RTOR) pilot program. The applications were granted Priority Review, with a target action date of August 17, 2021. The review of both applications will also be conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. The first sBLA is based on the phase III EV-301 trial and seeks to convert PADCEV's accelerated approval to regular approval. The second sBLA, based on the pivotal trial EV-201's cohort 2, requests an expansion of the current indication to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and are ineligible for cisplatin. Results from EV-301 were published in the New England Journal of Medicine. Results from EV-301 and EV-201 cohort 2 were presented at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium. See" Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma"- Thomas Powles, M.D., Jonathan E. Rosenberg, M.D., et al.-March 25, 2021 N Engl J Med 2021; 384:1125-1135 DOI: 10.1056/NEJMoa2035807.