In a groundbreaking development, AbbVie announces the U.S. FDA's approval of EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide for relapsed or refractory follicular lymphoma. This approval is a game-changer for patients who have been longing for new treatment options. But here's where it gets controversial: EPKINLY + R2 is the first and only bispecific antibody combination therapy available for these patients, but what does this mean for existing treatments? And this is the part most people miss: the Phase 3 EPCORE® FL-1 trial revealed that EPKINLY + R2 significantly outperformed the standard of care, with an impressive 3 out of 4 patients achieving a complete response.
This approval marks the third indication for EPKINLY and a historic first for bispecific combination therapy in lymphoma. The EPCORE FL-1 study demonstrated the potential of this therapy to transform FL treatment, offering hope to patients earlier in their journey. Dr. Lorenzo Falchi, a lymphoma specialist, highlights the significance of these results, emphasizing the need for new treatments to tackle this complex and persistent disease.
Follicular lymphoma, a slow-growing form of non-Hodgkin lymphoma, affects around 15,000 new patients annually in the U.S. Current therapies are considered incurable, and patients often relapse. In some cases, the disease can transform into a more aggressive form, diffuse large B-cell lymphoma.
The EPCORE FL-1 study included a diverse patient group, and EPKINLY + R2 reduced the risk of disease progression or death by a remarkable 79%. The overall response rate was 89% for EPKINLY + R2 compared to 74% for standard care. The median progression-free survival was not reached for EPKINLY + R2, while it was 11.2 months for standard care. Furthermore, 74% of patients on EPKINLY + R2 achieved a complete response, compared to 43% on standard care.
The safety profile of EPKINLY + R2 was generally consistent with known risks, with common adverse reactions including rash, upper respiratory tract infections, fatigue, and injection site reactions. The prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic problems. Meghan Gutierrez, CEO of the Lymphoma Research Foundation, emphasizes the significance of this approval, providing patients with more accessible treatment options.
EPKINLY + R2 was previously granted Breakthrough Therapy Designation by the FDA, expediting its development and review. With this approval, EPKINLY becomes the first bispecific antibody available for follicular lymphoma patients in the second-line setting. Dr. Daejin Abidoye from AbbVie highlights the need for new options to improve outcomes for relapsed or refractory patients.
EPKINLY monotherapy was granted accelerated approval in June 2024 for R/R FL after two or more lines of systemic therapy, and this approval has now been converted to full approval. The companies aim to pursue additional international regulatory approvals for this indication.
The EPCORE FL-1 trial data will be presented at the American Society of Hematology's Annual Meeting in December 2025, offering further insights into this promising therapy. EPKINLY, an IgG1-bispecific antibody, was created using Genmab's DuoBody® technology, designed to direct T cells to target B cells. Epcoritamab has received regulatory approval in over 65 countries for certain lymphoma indications and is being co-developed by Genmab and AbbVie.
The companies are evaluating epcoritamab as a monotherapy and in combination across therapy lines for various hematologic malignancies. AbbVie is committed to transforming cancer care, with a focus on targeted medicines and innovative treatment modalities. Their oncology portfolio includes approved and investigational treatments for blood cancers and solid tumors, and they are actively exploring solutions to improve patient access to these medicines.
As AbbVie continues to push boundaries in oncology, the question remains: how will this approval impact the landscape of follicular lymphoma treatment? Will it set a new standard of care, or will it face challenges from existing therapies? Share your thoughts and join the discussion on this exciting development in cancer research.
