CHMP recommends Tepkinly as a monotherapy for the treatment of patients with 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.

AbbVie's application for the approval of epcoritamab is supported by results from the pivotal EPCORE NHL-1 Phase 1/II open-label, multi-center trial evaluating the preliminary efficacy and safety of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including DLBCL. The primary endpoint of the study was overall response rate, as assessed by an independent review committee (63.1 percent). The most common treatment-emergent adverse event was cytokine release syndrome. Updated results were recently presented at multiple medical congresses.

"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, M.D., Ph.D., 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 being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.