– Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial –
– First and Only FDA-Approved Therapy for Urothelial Cancer Patients Who Are Cisplatin-Ineligible and Have Previously Received One or More Prior Therapies, Based on Cohort 2 of Pivotal EV-201 Trial –
San Francisco, CA (UroToday.com) — Seagen Inc. and Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) granted PADCEV® (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Cisplatin-ineligible patients typically have limited treatment options and a poor prognosis.