On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced it has granted accelerated approval of tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 

Tafasitamab-cxix is a monoclonal antibody. Monoclonal antibodies are the most common biologic agents used for lymphoma therapy. Antibodies produced by our immune system recognize and destroy “foreign” invaders such as bacteria and viruses. Scientists can now produce monoclonal antibodies in the laboratory that are designed to recognize antigens (specific molecules) that are present on the surface of certain cancer cells. Once in the bloodstream, monoclonal antibodies travel throughout the body and attach themselves to their specific target antigens. 

“This approval is a promising advancement for patients whose follicular lymphoma has returned or has not responded to prior lines of treatment,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We continue to celebrate every step toward improved outcomes for those touched by follicular lymphoma and congratulate those whose research contributions have helped this development.” 

For more information on the FDA approval of tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab, visit the  FDA’s website. To learn more about treatment options for follicular lymphoma, visit the Foundation’s follicular lymphoma learning center.