The EU Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for epcoritamab (Tepkinly) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
The final European Commission decision on this indication for epcoritamab is anticipated later this year.
If approved, epcoritamab will become the first and only subcutaneous bispecific antibody conditionally approved as a monotherapy for this patient group.
AbbVie’s application for the approval of epcoritamab is supported by results from the pivotal EPCORE NHL-1 Phase I/II trial evaluating the preliminary efficacy and safety of epcoritamab.
“DLBCL is an aggressive and often treatment-resistant disease with limited therapeutic options for patients whose disease is refractory or who have experienced relapse after multiple lines of therapy,” said Catherine Thieblemont, Head of the Hemato-oncology Department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “Subcutaneous epcoritamab could become a promising treatment option for the DLBCL community, and I look forward to the European Commission’s final decision.”
Epcoritamab is an investigational IgG1-bispecific antibody designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells. CD20 is expressed on B-cells and is a clinically validated therapeutic target in many B-cell malignancies, including DLBCL, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukaemia.
It is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialisation.