NORTH CHICAGO, Illinois, July 6, 2026
AbbVie has announced that the European Commission (EC) has granted marketing authorization for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). The approval marks a major advancement in the treatment of one of the most common forms of non-Hodgkin lymphoma (NHL) and establishes TEPKINLY + R2 as the first and only bispecific antibody-based therapy approved in Europe for second-line relapsed or refractory follicular lymphoma, offering patients a fixed-duration, chemotherapy-free treatment option. The approval is supported by the pivotal Phase 3 EPCORE® FL-1 trial, which demonstrated significant improvements in progression-free survival (PFS), overall response rate (ORR), and complete response (CR) compared with the current standard-of-care regimen of lenalidomide and rituximab alone. The latest regulatory milestone further strengthens AbbVie’s growing oncology portfolio and reinforces the expanding role of bispecific antibody immunotherapies in transforming the treatment landscape for hematologic malignancies.
Phase 3 EPCORE FL-1 Trial Demonstrates Significant Clinical Benefit
The European Commission’s approval is based on compelling results from the Phase 3 EPCORE FL-1 clinical trial, which enrolled patients with relapsed or refractory follicular lymphoma after at least one prior line of therapy. The study compared TEPKINLY plus lenalidomide and rituximab with lenalidomide and rituximab alone, demonstrating a 79% reduction in the risk of disease progression or death for patients receiving the bispecific antibody combination. The trial also reported an impressive overall response rate of 96% compared with 81% in the control group. Notably, approximately three out of every four patients (74%) achieved a complete response, substantially higher than the 43% complete response rate observed with standard therapy alone.
Investigators described these findings as clinically meaningful, highlighting the potential of fixed-duration, chemotherapy-free immunotherapy to improve long-term outcomes for patients who frequently experience repeated disease relapse and diminishing treatment options. The results position TEPKINLY as a promising new therapeutic option capable of changing the treatment paradigm for patients living with relapsed follicular lymphoma.
Bispecific Antibody Therapy Expands Precision Immuno-Oncology
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TEPKINLY (epcoritamab) is a subcutaneously administered IgG1 bispecific antibody developed using Genmab’s proprietary DuoBody® technology and co-developed through AbbVie’s global oncology collaboration with Genmab. The therapy simultaneously binds to CD3 receptors on T cells and CD20 proteins on malignant B cells, redirecting the patient’s immune system to selectively eliminate cancerous B cells through T-cell-mediated cytotoxicity. Unlike traditional chemotherapy, this targeted immunotherapy approach offers a more precise mechanism of action while reducing dependence on cytotoxic treatment regimens.
The newly approved combination also provides patients with a fixed-duration treatment schedule, representing an important advancement in quality of life by reducing prolonged treatment exposure. Although adverse events including cytokine release syndrome (CRS), neutropenia, infections, fatigue, anemia, thrombocytopenia, and pneumonia were observed, the overall safety profile remained consistent with previous clinical experience and the known safety characteristics of the individual treatment components. The approval further validates the growing clinical value of bispecific antibody therapies across hematologic cancers.
AbbVie Strengthens Leadership in Hematologic Cancer Innovation
The latest European approval reinforces AbbVie’s commitment to advancing innovative oncology therapies for patients with difficult-to-treat blood cancers. Through its expanding collaboration with Genmab, the company continues evaluating epcoritamab across multiple Phase 3 clinical trials involving diffuse large B-cell lymphoma (DLBCL), previously untreated follicular lymphoma, and additional hematologic malignancies. Currently approved in more than 65 countries for selected lymphoma indications, epcoritamab continues to demonstrate broad therapeutic potential as part of AbbVie’s expanding immuno-oncology pipeline.
The company is advancing more than 35 investigational oncology medicines spanning blood cancers and solid tumors while investing in innovative treatment platforms including bispecific antibodies, antibody-drug conjugates, CAR-T therapies, and targeted small molecules. The European Commission’s approval of TEPKINLY® plus lenalidomide and rituximab represents another important milestone in delivering precision immunotherapies that improve survival outcomes while offering patients more effective, chemotherapy-free treatment alternatives for relapsed or refractory follicular lymphoma.
Source: AbbVie press release
