ShanghaiMay 15, 2026 /PRNewswire/ — AbbVie today announced that Epcoritamab (Epkinly®) has been approved by China’s National Medical Products Administration (NMPA) for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). It is the first bispecific antibody approved for second-line or later R/R FL and pioneeringly adopts a subcutaneous injection administration route, offering new hope for patients.
Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) originating from abnormal proliferation of B lymphocytes, classified as an indolent lymphoma subtype[1]. Its incidence rate in China is lower than in Western countries, but it shows a trend toward younger patients, with a median age of onset around 50 years[2]. Follicular lymphoma is currently incurable, and patients experience repeated relapses, with survival prognosis progressively worsening as the number of relapses increases[3]. Among these, patients who experience early disease progression within 24 months (POD24) after starting first-line treatment have a lower 5-year overall survival rate[4].
Epkinly® employs a novel mechanism of action, binding CD20 and CD3 in a 1:1 ratio[5] to activate T cells to kill malignant B cells. In the Fc segment of its antibody structure, some effector functions are designed to be silenced. This mechanism is significant in treating follicular lymphoma, as it can reduce the risk of adverse reactions caused by excessive immune system activation.
This approval is based on the pivotal global Phase 3 EPCORE® FL-1 study. The study compared the efficacy of a fixed-duration regimen of epcoritamab combined with R2 (lenalidomide and rituximab) versus the standard R2 regimen in patients with relapsed/refractory follicular lymphoma (FL). Results show that this combination regimen has the potential to redefine the FL treatment landscape, enabling patients to benefit earlier.
The EPCORE® FL-1 study enrolled a broad patient population, including FL patients who had received from first-line to multiple prior lines of therapy.
Compared to the R2 regimen, treatment with epcoritamab + R2 significantly reduced the risk of disease progression or death by 79% (HR=0.21, 95%CI: 0.14-0.31, p<0.0001).
Efficacy data across all dimensions were excellent:
Overall Response Rate (ORR): Epcoritamab + R2 group 95% vs R2 group 79% (p<0.0001)
Complete Response Rate (CR): Epcoritamab + R2 group 83% vs R2 group 50% (p<0.0001)
Median Progression-Free Survival (PFS): Epcoritamab + R2 group not yet reached (NR), R2 group only 11.7 months
Overall Survival (OS) Rate: The 16-month OS rate for epcoritamab + R2 was 95.8%, significantly higher than the R2 group’s 88.8%, P<0.0039
Time to Next Treatment (TTNT): After 16 months of treatment, 92.8% of patients in the epcoritamab + R2 group did not require subsequent therapy, compared to only 64.9% in the R2 group, P<0.0001
In the EPCORE FL-1 study, the safety profile of the Epkinly® plus R2 regimen was generally consistent with the control group and known safety profiles.
Professor Zhao Weili, Vice President of Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, stated: “First-line chemoimmunotherapy for FL can provide patients with relatively durable remission, but once relapse occurs, the duration of remission from subsequent treatments progressively shortens. In the treatment of relapsed/refractory FL, there remain unmet clinical needs such as limited efficacy and the need for improved safety. Current treatment options struggle to achieve deep and durable remission, patients face a high risk of relapse, and treatment choices are limited. There is an urgent clinical need for more breakthrough treatment options.”
“The approval of Epkinly® marks a new era in the treatment of follicular lymphoma in China,” said Professor Huang Huiqiang from Sun Yat-sen University Cancer Center. “Compared to the R2 regimen alone, the Epkinly® plus R2 regimen demonstrates superior response rates and disease control, enabling patients to achieve deeper and more durable remission. This chemotherapy-free regimen, administered via subcutaneous injection, is more convenient and will significantly improve patient compliance, quality of life, and treatment experience.”
Professor Ma Jun, Director of the Harbin Institute of Hematology and Oncology, stated: “The treatment of relapsed/refractory FL has evolved from a model primarily based on radiotherapy and single targeted drugs to a treatment landscape where multiple therapies complement and synergize. New treatment options, while improving tolerability and safety, can better achieve long-term disease control, helping patients attain high-quality long-term survival. With the approval of Epkinly® in China, this drug has been included in the latest edition of the CSCO Guidelines for the Diagnosis and Treatment of Lymphoma (2026). We look forward to this internationally advanced treatment regimen benefiting more Chinese follicular lymphoma patients as soon as possible, aligning China’s diagnosis and treatment levels with global standards.”
Dong Lijun, Vice President of AbbVie and General Manager of AbbVie China (Mainland China, Hong Kong, and Macau), stated: “The approval of Epkinly® is a significant milestone for AbbVie in our continued deep commitment to hematologic oncology and our ongoing efforts to redefine treatment standards, fully reflecting our patient-centric approach and steadfast commitment to advancing medical innovation. Epkinly® has accumulated nearly three years of clinical application experience in dozens of countries and regions globally. We look forward to this new chemotherapy-free treatment option benefiting Chinese patients as soon as possible. In the future, AbbVie will work hand in hand with the broader medical community to jointly elevate the level of lymphoma diagnosis and treatment in China to new heights.”
- NCCN: B-Cell Lymphomas. Version 5.2021
- Zha J, et al. J Hematol Oncol 2021; 14(1):131.