The U.S. Food and Drug Administration (FDA) Grants Accelerated Approval to Epcoritamab-Bysp (Epkinly) for Relapsed or Refractory Follicular Lymphoma

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On June 26, 2024, the U.S. Food and Drug Administration (FDA) announced it has granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior 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 whose disease has returned or has not responded to prior lines of treatment,” 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 follicular lymphoma.” 

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

Learn More About Bispecific Antibodies