• Approval based on results from two Phase 1/2 EPCORE® clinical trials, which demonstrated strong and durable efficacy in patients with relapsed or refractory (R/R) follicular lymphoma (FL) who had received two or more lines of systemic therapy
• EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan to treat both R/R FL and R/R large B-cell lymphomas, after two or more prior lines of therapy
• EPKINLY is the only bispecific antibody approved with a dual indication for the treatment of certain B-cell malignancies in the United States, European Union and Japan

Genmab A/S (NASDAQ:GMAB) announced today that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy. With this additional indication, EPKINLY is now the first and only T-cell engaging bispecific antibody administered subcutaneously to be approved in Japan to treat both R/R FL and R/R large B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more prior lines of therapy.

FL is typically an indolent (or slow growing) form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL, accounting for 20-30 percent of all cases.i There are approximately 19,000 patients currently living with FL in Japan.ii FL is considered incurable with current standard of care therapies.iii Patients often relapse and, with each relapse, the remission and time to next treatment is shorter.iv Over time, transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v