Epcoritamab has received regulatory approval in Japan to treat Grade 1 to 3A relapsed or refractory follicular lymphoma (FL) in adults following at least two lines of therapy. The agent is also approved for large B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and primary mediastinal large B-cell lymphoma. Japan’s Ministry of Health, Labour and Welfare (MHLW) issued the new approval for epcoritamab and the approval was announced in a media release from Genmab, a codeveloper of the agent.
Epcoritamab is a subcutaneously administered IgG1-bispecific antibody being co-produced by Genmab and Abbvie. Through a Genmab proprietary development process, the agent binds to CD3 on T cells and CD20 on B cells and enables T-cell elimination of CD20+ cells.
In Japan and the US, epcoritamab is branded as EPKINLY and as TEPKINLY in the European Union. It has previously received regulatory approvals in the US and European Union for certain types of DLBCL, high-grade B-cell lymphoma, or FL that have not responded to two or more treatments.
“Over the last year, EPKINLY has been approved in the U.S., the European Union (as TEPKINLY), and Japan. With a dual indication in relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after two or more prior therapies, we are committed to making epcoritamab available to patients in need and continuing its broad development as a potential core therapy across B-cell malignancies,” wrote Genmab executive vice president and chief development officer Judith Klimovsky, MD.
MHLW based its approval on results from the global phase I/II EPCORE NHL-1 and the Japan-based phase I/II EPCORE NHL-3 open-label clinical trials. In these trials, which applied differing dose escalation methods to evaluate epcoritamab as monotherapy for relapsed or refractory mature B-cell non-Hodgkin’s lymphomas, the agent demonstrated impressive efficacy for treating FL.
“The responses and tolerability demonstrated in this trial support the potential of epcoritamab to become an important option in future treatment strategies for relapsed/refractory follicular lymphoma,” commented EPCORE NHL-3 trial principal investigator Koji Izutsu, MD, PhD, of the National Cancer Center Hospital, Tokyo, Japan.
In several different countries, Genmab and Abbvie are seeking additional regulatory approvals for epcoritamab related to the DLBCL and FL indications. They are also conducting several clinical trials to evaluate the agent, including five ongoing phase III, open-label, randomized trials in relapsed or refractory DLBCL and FL. Their polytherapy studies evaluate epcoritamab in combination or comparison with rituximab and lenalidomide, chemotherapy regimens, or chemoimmunotherapy.
Reference
EPKINLY (epcoritamab) approved by Japan Ministry of Health, Labour and Welfare for additional indication as a treatment for relapsed or refractory follicular lymphoma. News release. Genmab. February 20, 2025. Accessed February 21, 2025. https://ir.genmab.com/news-releases/news-release-details/epkinlyr-epcoritamab-approved-japan-ministry-health-labour-and
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