Seagen/Astellas Pharma Seek Approval For PADCEV's Expanded Use In Urothelial Cancer Settings

Seagen Inc (NASDAQ: SGEN) and its collaborating partner Astellas Pharma Inc ALPMF have submitted two supplemental marketing applications to the FDA for PADCEV (enfortumab vedotin-ejfv).
Based on phase 3 EV-301 trial, one submission seeks to convert PADCEV's accelerated approval to regular approval. Based on the pivotal trial EV-201's second cohort, the second submission 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 the Real-Time Oncology Review pilot program that aims to explore a more efficient review process.
In 2019 PADCEV received accelerated approval in the U.S. for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery in a locally advanced or metastatic urothelial cancer setting. PADCEV is currently only approved for use in the U.S.
Price Action: SGEN closed 0.3% lower at $158.83 on Wednesday.