The U.S. Food and Drug Administration (FDA) Approves Epcoritamab-bysp for Follicular Lymphoma Indications

November 18, 2025 – On November 18, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy

Epcoritamab-bysp (Epkinly, Genmab US, Inc.) is a bispecific antibody. Bispecific antibodies are engineered hybrid molecules with two unique binding domains, each of which recognizes a certain target, unlike monoclonal antibodies that have two arms that both recognize the same target antigen.  

“This approval is an exciting development for patients with follicular lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We applaud those whose research contributions, including patients participating in clinical trials, have helped to ensure brighter futures for those touched by this disease.”

For more information on the FDA approval of epcoritamab-bysp (Epkinly, Genmab US, Inc.), visit the FDA’s website. To learn more about treatment options for follicular lymphoma, visit the Foundation’s follicular lymphoma learning center.