Genmab has filed a Japan new drug application (JNDA) with the Ministry of Health, Labor and Welfare (MHLW) of the country for subcutaneous epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) large B-cell lymphoma (LBCL) patients.
The treatment is intended for such patients who have previously received two or more lines of systemic therapy.
The JNDA filing is backed by the multicentre, open-label Phase II EPCORE NHL-3 clinical trial which assessed the safety and initial efficacy of epcoritamab in adult relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL) patients in Japan.
The submission also comprised data from international, open-label, multicentre Phase II EPCORE NHL-1 trial of epcoritamab in the same group of patients.
Being developed jointly by Genmab and AbbVie under an oncology partnership, epcoritamab is an investigational IgG1-bispecific antibody.
Genmab CEO Jan van de Winkel said: “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.
“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.”
In November this year, the company received Priority Review for the Biologics License Application (BLA) of epcoritamab to treat R/R LBCL from the US Food and Drug Administration (FDA).
A decision on the FDA approval is anticipated by 21 May next year.
In addition, the Marketing Authorization Application (MAA) for epcoritamab for R/R diffuse LBCL was validated by the European Medicines Agency recently.