CPH:GMAB — Submission of sBLA to FDA for Epcoritamab
Jun 30, 2025, 12:00:00 AM UTC
Summary
Genmab A/S plans to submit a supplemental Biologics License Application (sBLA) to the U.S. FDA for Epcoritamab in combination with Rituximab and Lenalidomide for the treatment of relapsed/refractory follicular lymphoma. This decision follows positive results from the Phase 3 EPCORE FL-1 trial, which demonstrated a significant overall response rate. The submission is part of Genmab's strategy to advance novel therapies for patients in need, with full trial results expected to be presented at a medical conference in 2025.
Company
Genmab (CPH:GMAB)CPH — Health Care,
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