Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

Company Announcement Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1 trialFull results from the trial will be submitted for presentation at an upcoming medical conference in 2025 COPENHAGEN, Denmark; May 2, 2024 – Genmab A/S (Nasdaq: GMAB) announced today its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ...