Highlights 

  • Genmab secures full FDA approval for EPKINLY combination therapy in R/R follicular lymphoma. 
  • EPKINLY + R2 becomes the first FDA-approved bispecific combination regimen in lymphoma. 
  • Approval based on confirmatory Phase 3 EPCORE FL-1 study results. 
  • EPKINLY’s prior accelerated monotherapy approval is now converted to full approval. 
  • GMAB shares saw a slight uptick in after-hours trading following the announcement. 

Genmab A/S (NASDAQ:GMAB) has received a major regulatory milestone with the U.S.Food and Drug Administrationgranting approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide, collectively known as EPKINLY + R2, for adults with relapsed or refractory follicular lymphoma. This approval introduces the first-ever FDA-authorized bispecific combination therapy in lymphoma, marking a noteworthy development for treatment of the disease. 

Follicular lymphoma, a slow-growing form of non-Hodgkin lymphoma, often requires repeated treatment due to relapse patterns. The EPKINLY + R2 regimen aims to provide patients with an alternative therapeutic option that leverages bispecific T-cell–engaging technology while pairing it with two widely used therapy components—rituximab and lenalidomide. 

Phase 3 EPCORE FL-1 Study Supports Regulatory Decision 

The FDA’s approval was supported by findings from the confirmatory Phase 3 EPCORE FL-1 trial, which established the effectiveness and safety profile of EPKINLY when used as part of this combination. The results helped validate EPKINLY’s role beyond monotherapy and contributed directly to the FDA converting its June 2024 accelerated approval into full approval. 

In its earlier accelerated approval, EPKINLY monotherapy was cleared for use in patients with R/R FL who had already undergone two or more systemic therapies. The latest decision not only reinforces the data behind that earlier authorization but also expands the treatment landscape by endorsing the combination as a fully approved regimen. For clinicians and patients, this translates into a new and potentially more impactful therapeutic option at earlier stages of relapsed disease management. 

Genmab emphasized that this approval represents the therapy’s third overall indication, further strengthening its oncology portfolio and validating the company’s ongoing investment in next-generation antibody therapeutics. 

Market Reaction and Future Outlook 

Genmab’ shares previously closed at USD 30.32, marking a 0.33% decrease from the prior session.   

With the new approval, Genmab is expected to deepen its foothold in the lymphoma treatment landscape, potentially driving increased uptake of EPKINLY as physicians evaluate combination regimens for R/R FL patients. The company aims to collaborate with prescribers and treatment centers to accelerate adoption and integrate the therapy into clinical practice. 

Conclusion 

Genmab’s newly secured FDA approval for EPKINLY + R2 represents a meaningful advancement in follicular lymphoma treatment and a significant achievement for bispecific antibody technology. The conversion of EPKINLY’s accelerated monotherapy approval into a full approval—coupled with the introduction of the first bispecific combination regimen—positions the therapy as a compelling option for individuals facing relapsed or refractory FL. As Genmab advances its oncology pipeline, this approval strengthens both its scientific validation and strategic direction in hematologic cancers. 

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