Epkinly (epcoritamab) is approved by MHLW (Japan) as the first bispecific antibody to treat adults patients with certain types of relapsed or refractory (r/r) large B-cell lymphoma
Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved Epkinly (epcoritamab) as the first and only T-cell engaging bispecific antibody treatment in Japan of adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy
Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.
“Despite recent advances in the treatment of LBCL, the prognosis for patients with relapsed/refractory LBCL remains generally poor, and there is a need for additional treatment options for patients whose condition has worsened after multiple lines of treatment,” said Koji Izutsu, MD, PhD, principal investigator of the phase 1/2 EPCORE NHL-3 trial in Japan and Head of the Hematology Department, National Cancer Center Hospital. “In the EPCORE NHL-3 trial, subcutaneous epcoritamab monotherapy demonstrated responses in a considerable number of patients with relapsed/refractory DLBCL, indicating that this approval is of great significance.”
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