AbbVie just scored a major regulatory win at home base. The company’s cancer drug Epkinly has been cleared by the U.S. Food and Drug Administration to be used with rituximab and lenalidomide in adults with relapsed or refractory follicular lymphoma. The Tuesday decision, built on a randomized Phase 3 study, could move the North Chicago drugmaker’s bispecific antibody into earlier treatment lines for a disease that has an unfortunate habit of coming back after standard therapy.
FDA Signs Off On Epkinly Plus R2
In a press release, AbbVie said the FDA approved Epkinly (epcoritamab-bysp) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma, and that the label expansion is supported by data from the Phase 3 EPCORE FL-1 trial. According to AbbVie, the move also converts Epkinly’s earlier accelerated monotherapy approval into a broader traditional approval.
Phase 3 Results Were Striking
Genmab said in a press release that the EPCORE FL-1 study showed Epkinly plus R2 cut the risk of disease progression or death by 79% compared with R2 alone, with a hazard ratio of 0.21. The company reported an overall response rate of about 89% for the combination versus 74% for R2 alone. Roughly 74% of patients on the Epkinly combo achieved a complete response compared with 43% on R2, and the partners plan to present full trial data at the American Society of Hematology meeting in December.
Safety And Warnings
The FDA approval comes with a boxed warning for serious or potentially life-threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The label calls for step-up dosing and close monitoring to help manage those risks. Prescribing information also lists common side effects that include rash, upper respiratory infections, fatigue, and injection-site reactions. For full safety details, the agency directs prescribers to the FDA announcement on the approval.
What This Means For Patients And The Market
Companies involved say this is the third indication for Epkinly and, crucially, the first bispecific-antibody combination cleared for follicular lymphoma in the second-line setting. That shift could meaningfully change treatment options for patients who relapse after their initial therapy. Genmab and AbbVie will jointly handle commercialization in the United States and Japan, while AbbVie takes the lead in the rest of the world, according to the companies. Analyst reports indicate Epkinly generated about $69 million in the third quarter of 2025, a modest but growing slice of the partners’ oncology portfolios.
Local Impact In North Chicago
AbbVie, headquartered in North Chicago, has been ramping up its domestic manufacturing footprint, including a new active pharmaceutical ingredient facility the company expects to have online around 2027. The buildout, which AbbVie has tied to its broader oncology and biologics strategy, is positioned to support production of next-generation therapies and help sustain manufacturing jobs in the region as Epkinly’s use expands. PR Newswire has additional details on the project.
