Diffuse large B-cell lymphoma treatment Minuvi wins permit in Korea
Minjuvi, a treatment for diffuse large B-cell lymphoma (DLBCL) imported by Handok, won marketing approval on Monday.
The Ministry of Food and Drug Safety (MFDS) announced that it has approved Minjuvi (tafasitamab), an orphan drug used to treat DLBCL.
DLBCL, one of the most common lymphomas, is a rapidly progressive blood cancer.
Minjuvi is indicated for use in combination with lenalidomide in adult patients with relapsed or refractory DLBCL who are not candidates for an autologous hematopoietic stem cell transplant and who have failed one or more prior therapies, and may then be used as monotherapy afterward.
Minzuvi offers a new therapeutic opportunity in DLBCL by binding to CD19, a cell surface antigen protein specific to normal and malignant B lymphocytes, and inducing direct cell death, antibody-dependent phagocytosis, and antibody-dependent cell-mediated cytotoxicity, resulting in B-cell depletion.
The drug is an immunoglobulin (IgG) subtype humanized monoclonal antibody that targets CD19.