Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Fo...
Genmab A/S - American Depositary Shares (GMAB)
Company Research
Source: GlobeNewswire
Company Announcement EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line settingIn the Phase 3 EPCORE® FL-1 trial, fixed duration EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2, with approximately three out of four patients achieving a complete responseThis approval marks the third indication for EPKINLY and the first-ever FDA approval for a bispecific combination therapy in the lymphoma space COPENHAGEN, Denmark; November 18, 2025 – Genmab A/S (Nasdaq: GMAB) announced today that EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE® FL-1 study that e
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