Enfortumab vedotin accepted for priority review by FDA

The US Food and Drug Administration has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial (bladder) cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

The filing, submitted by US biotech Seattle Genetics (Nasdaq: SGEN) and partner Japan’s Astellas (TYO: 4503), is based on results from the first cohort of patients in the EV-201 pivotal Phase II clinical trial that were presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2019.

In July, analysts at Stifel estimated that enfortumab vedotin will generate North America sales of about $367 million in 2024.