DuoBody-CD3xCD20 filed with MHLW (Japan) to treat large B-cell lymphoma.- Genmab
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 (DuoBody-CD3xCD20), 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 II 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.
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