Genmab Secures European Approval for TEPKINLY Combo Therapy in Follicular Lymphoma
Event summary
- European Commission approved TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab for relapsed/refractory follicular lymphoma on July 6, 2026.
- Phase 3 EPCORE FL-1 trial showed TEPKINLY + R2 reduced risk of disease progression or death by 79% compared to standard of care (HR 0.21).
- Overall response rate was 96% for TEPKINLY + R2 versus 81% for R2 alone, with 74% achieving complete response.
- TEPKINLY is the first bispecific-based therapy approved in Europe for second-line follicular lymphoma treatment.
The big picture
This approval positions TEPKINLY as a frontline option for follicular lymphoma, addressing an unmet need in the second-line setting. The success of combination therapies is reshaping treatment paradigms in oncology, with bispecific antibodies emerging as key drivers. Genmab's collaboration with AbbVie enhances its commercial reach while validating its DuoBody technology platform.
What we're watching
- Commercial Strategy
- How Genmab and AbbVie will leverage this approval to expand TEPKINLY's market penetration in Europe.
- Pipeline Expansion
- The pace at which additional indications for epcoritamab will be pursued globally.
- Competitive Positioning
- Whether this approval strengthens Genmab's leadership in bispecific antibody therapies for B-cell malignancies.
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