AbbVie announced that EPKINLY (epcoritamab-bysp), a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab and lenalidomide (EPKINLY + R2) is approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL). This approval of EPKINLY is based on results from the pivotal Phase 3 EPCORE FL-1 study that evaluated fixed duration EPKINLY + R2 compared to standard of care R2 and demonstrates the potential of this combination therapy to reshape FL treatment and to reach patients earlier in their treatment.

"Recurrent Follicular Lymphoma can be an incurable, complex and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey. The results shown with EPKINLY + R2 in the EPCORE FL-1 study are meaningful, demonstrating durable responses compared to patients treated with R2 alone. These data, delivered by a regimen that's chemotherapy-free and can be administered in the outpatient setting, suggest that EPKINLY + R2 could potentially become a new standard of care," said Lorenzo Falchi, MD, lymphoma specialist, department of medicine, Memorial Sloan Kettering Cancer Center.

FL is typically an indolent (slow-growing) form of Non-Hodgkin Lymphoma (NHL) that arises from B-lymphocytes and impacts approximately 15,000 new patients per year in the US. The disease is considered incurable with current available therapies. Patients with FL often relapse, and in some cases, the disease can transform into a more aggressive form of NHL called Diffuse Large B-Cell Lymphoma (DLBCL).

"Today's milestone marks meaningful progress for people living with Follicular Lymphoma. With a bispecific-based therapy that can be administered in a variety of medical settings, patients have the possibility of accessing this treatment at sites of care closer to where they live," said Meghan Gutierrez, Chief Executive Officer (CEO), Lymphoma Research Foundation.

EPKINLY + R2 was previously granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R FL. This designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

"With this approval, EPKINLY is now the first bispecific antibody available for patients with Follicular Lymphoma in the second-line plus setting. New options are needed to improve outcomes for patients with relapsed or refractory disease," said Daejin Abidoye, MD, Vice President, Therapeutic Area Head, Oncology, Solid Tumour and Hematology, AbbVie.

In June 2024, EPKINLY monotherapy was granted accelerated approval by the FDA for the treatment of R/R FL following two or more lines of systemic therapy. With the results of the confirmatory Phase 3 EPCORE FL-1 study, the FDA has also converted this accelerated approval to a full approval. Both companies will pursue additional international regulatory approvals for the R/R FL indication.

Data from the Phase 3 EPCORE FL-1 study will be presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2025.