NORTH CHICAGO, IL – November 18, 2025 — AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab-bysp) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory Follicular Lymphoma (FL) after at least one prior systemic therapy. This approval marks the first bispecific antibody combination therapy authorized for FL, supported by pivotal phase 3 results showing a 79% reduction in risk of disease progression or death and an 89% overall response rate, demonstrating substantial benefit in a patient population with persistent unmet needs.
Science Significance
Epkinly is a CD3×CD20 bispecific antibody that enables T-cell–mediated killing of CD20-positive lymphoma cells by physically bridging T cells and malignant B cells. This mechanism delivers potent immune cytotoxicity and enhances anti-tumor activity beyond traditional monoclonal antibody therapy. When used alongside rituximab and lenalidomide, the regimen forms a synergistic immunotherapy platform that amplifies both innate and adaptive immune responses. Trial outcomes—including an 89% overall response rate and nearly 75% complete response rate—underscore the scientific strength of bispecific engagement and demonstrate its potential to redefine immunotherapy standards in B-cell malignancies.
Regulatory Significance
Regulatory authorities evaluated the therapy’s clinical robustness, particularly regarding cytokine release syndrome (CRS), neurological effects, and step-up dosing requirements. The FDA concluded that Epkinly + R² demonstrates a favorable benefit-risk profile suitable for outpatient administration. As the first approved bispecific-antibody combination for FL, the decision signals expanding regulatory openness to next-generation immunotherapies backed by strong mechanistic data. This approval may also accelerate regulatory pathways for similar bispecific combinations in future oncology indications.
Business Significance
Advertisement
For AbbVie and its development partner Genmab, this approval strengthens competitive positioning in the growing market for lymphoma therapies. FL represents a large and recurrent treatment population, making effective second-line therapies commercially relevant. Epkinly’s subcutaneous administration, paired with strong clinical outcomes, supports broad integration across oncology centers and community settings. The therapy is well-positioned to become a major revenue driver as part of AbbVie’s expanding oncology portfolio, with potential application across multiple B-cell malignancies under ongoing investigation.
Patients’ Significance
For patients, the approval delivers a meaningful advancement—especially for individuals who experience relapse soon after initial therapy. The high response and complete remission rates offer hope for longer, deeper, and more durable remissions. Additionally, the subcutaneous dosing provides a more convenient alternative to infusion-based treatments, reducing treatment burden and increasing accessibility for individuals receiving care in community clinics. For many patients, this combination may delay disease progression significantly and improve long-term quality of life.
Policy Significance
This approval aligns with policy priorities encouraging wider adoption of innovative, effective cancer immunotherapies, particularly those suitable for outpatient care. As healthcare systems advocate for cost-effective oncology solutions and reduced reliance on inpatient services, the subcutaneous delivery model supports evolving reimbursement frameworks. The treatment also aligns with regulatory and public-health goals promoting progress in orphan disease therapies, immune-oncology innovation, and value-based cancer care.
AbbVie’s FDA approval of Epkinly (epcoritamab-bysp) in combination with rituximab and lenalidomide marks a defining advancement in the treatment of relapsed or refractory follicular lymphoma. With strong phase 3 efficacy, a novel bispecific mechanism, and broad clinical accessibility, Epkinly + R² represents a powerful new standard for FL care. This milestone reinforces the accelerating role of bispecific T-cell engagers in hematologic oncology and highlights AbbVie’s leadership in developing next-generation cancer therapeutics that deliver meaningful benefits to patients.
Source: AbbVie press release
