This marks Epkinly as the first subcutaneously administered T-cell engaging bispecific antibody approved in the country for R/R follicular lymphoma as well as R/R large B-cell lymphomas.
The approval is anchored on data from the multicentre Phase I/II global EPCORE NHL-1 trial and the EPCORE NHL-3 trial in Japan.
These open-label studies assessed the therapy’s efficacy and safety as a single agent in subjects with R/R mature B-cell non-Hodgkin’s lymphoma, including follicular lymphoma.
EPCORE NHL-3 trial principal investigator and National Cancer Center Hospital Department of Hematology head Dr Koji Izutsu said: “In the treatment of follicular lymphoma, where options become limited with each relapse, there remains a high unmet need for third-line and subsequent therapies in the absence of a clear standard of care.
“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.”
An Immunoglobulin G1 (IgG1)-bispecific antibody, epcoritamab is developed leveraging the company’s DuoBody technology.
It is the sole antibody that has received approval for dual indications in the treatment of specific B-cell malignancies in the European Union, the US and Japan.
Genmab and AbbVie are co-developing the therapy as part of their oncology partnership.
Follicular lymphoma, a slow form of non-Hodgkin’s lymphoma, originates from B-lymphocytes and represents 20-30% of all non-Hodgkin’s lymphoma cases.