Genmab Submits NDA For Epcoritamab In Japan For Relapsed/Refractory Large B-Cell Lymphoma

(RTTNews) - Genmab A/S (GMAB) announced Wednesday 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 (DuoBody-CD3xCD20)

Epcoritamab is an investigational bispecific antibody, for the treatment of patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) 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 (GCT3013-04) 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 (B-NHL), as well as results from the global EPCORE NHL-1 open-label, multi-center, phase 2 trial (GCT3013-01) evaluating epcoritamab in the same patient population.

Epcoritamab is being co-developed by Genmab and AbbVie 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.

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