Genmab submits JNDA for epcoritamab to treat patients with R/R LBCL

Genmab announced that the company has submitted a Japan new drug application JNDA to the Ministry of Health, Labor and Welfare, MHLW, of Japan for subcutaneous epcoritamab , an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy. The JNDA submission is supported by the EPCORE NHL-3, open-label, multi-center, phase 2 trial evaluating the safety and preliminary efficacy of epcoritamab in adult patients in Japan with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma , as well as results from the global EPCORE NHL-1 open-label, multi-center, phase 2 trial evaluating epcoritamab in the same patient population. "With this regulatory submission, we are one step closer to potentially delivering epcoritamab as a new therapeutic option to patients in Japan with relapsed and refractory LBCL who are in need of alternative treatments," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab and our partner AbbVie believe that epcoritamab has the potential to become a core therapy for patients around the world with B-cell malignancies and we are committed to progressing the comprehensive development program evaluating epcoritamab across a broad range of B-cell lymphomas."