This update applies to patients in the United States.
On 18 November 2025, the U.S. Food & Drug Administration (FDA) approved epcoritamab-bysp (EPKINLY®) in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) who have received at least one prior systemic therapy. Approval outside the U.S. has not yet been granted
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Who could benefit from this newly approved combination?
This treatment is approved for adults whose FL has returned (relapsed) or has not responded (is refractory) after at least one earlier line of therapy. Because FL often relapses over time, having additional options gives patients and clinicians more flexibility in choosing what might work best at each stage of the journey.
What evidence supports the FDA approval?
The approval is based on results from a large clinical study called EPCORE FL-1, which tested the combination in people with relapsed or refractory FL.
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In the Study:
Most people responded well to treatment. Nearly 9 out of 10 patients (89%) saw their lymphoma shrink or disappear. 74% achieved a complete response.
The combination worked better than the existing standard option. Compared with rituximab and lenalidomide alone, adding epcoritamab-bysp helped people stay in remission for longer and reduced the chance of their lymphoma worsening.
People stayed well for longer. At the time of analysis, many people on the new combination were still doing well, so researchers could not yet calculate the average time before the lymphoma returned. For those receiving the standard treatment alone, this time was just over 11 months.
These findings suggest that this combination may offer deeper and longer-lasting responses for many patients with relapsed or refractory FL.
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What toxicities or side effects are linked to this therapy?
As with other T-cell engaging treatments, this combination can lead to side effects, including:
– Cytokine Release Syndrome (CRS)
– Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
– Infections
– Low blood counts (cytopenias)
– Fatigue
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Why does this approval matter?
For individuals living with FL, this U.S. approval offers another non-chemotherapy, fixed-duration treatment option. Because FL is a long-term condition that often requires multiple treatments over time, having an additional approach may help people and their clinicians tailor care more closely to their needs and preferences.
In conclusionÂ
The approval of epcoritamab-bysp (EPKINLY®) in combination with rituximab and lenalidomide provides adults in the United States with a new treatment option for relapsed or refractory follicular lymphoma. We encourage people living with FL to speak with their clinical teams about whether this therapy may be appropriate for their individual situation.
