AbbVie Inc. (ABBV) announced that the FDA has approved EPKINLY in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma.
EPKINLY is a T-cell-engaging bispecific antibody designed to target CD20 on B-cells and CD3 on T-cells. In this newly approved regimen, it is administered subcutaneously with R2 (rituximab and lenalidomide), offering a fixed-duration, chemotherapy-free option for patients.
The approval was based on results from a phase 3 trial, dubbed EPCORE FL-1. The results demonstrated that the combination reduced the risk of disease progression or death by 79% compared to R2 alone.
Overall response rates reached 89% in the EPKINLY + R2 arm versus 74% in the control group, with complete response observed in 74% of patients compared to 43% with R2. Median progression-free survival was not reached in the EPKINLY + R2 group, highlighting durable benefit.
Safety data indicated that the regimen was generally manageable, with the added advantage of being chemotherapy-free and suitable for outpatient administration.
Data from the EPCORE FL-1 study will be presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2025, providing further visibility into the clinical impact of this therapy.
AbbVie is collaborating with Genmab A/S (GMAB) on the development of EPKINLY. Under the agreement signed in 2020, the companies will share commercial responsibilities in the U.S. and Japan, while AbbVie will lead commercialisation in the rest of the world. Genmab will record net sales in the U.S. and Japan and receive tiered royalties on sales in other global markets.
ABBV has traded in the range of $164.39 to $244.81 over the past year. The stock closed yesterday's trading at $233.87, down 0.06%.
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