TEPKINLY (epcoritamab) is the first and only subcutaneous bispecific antibody conditionally approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of prior therapy FL is an incurable form of non-Hodgkin's lymphoma (NHL), with about 13,000 estimated cases in Western Europe alone each year 1 NORTH CHICAGO, Ill. , Aug. 19, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY ® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.
TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the European Union (EU), as well as the European Economic Area (EEA) countries ( Iceland , Liechtenstein , Norway ) and Northern Ireland . "The European approval of TEPKINLY for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop TEPKINLY as a potential core therapy across multiple B-cell malignancies. First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a hema.