Tafasitamab (MOR208) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody directed against CD19 in clinical development for the treatment of B cell malignancies.
Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody directed against the antigen CD19 which is broadly expressed on the surface of B cells. It is therefore considered as a potential target for the treatment of B cell malignancies, such as non-Hodgkin’s lymphoma (NHL), including diffuse large B cell lymphoma (DLBCL), indolent lymphomas like follicular lymphoma (FL) and marginal zone lymphomas (MZL), as well as chronic lymphocytic leukemia (CLL). The main development focus of tafasitamab (MOR208) is on the treatment of patients with DLBCL. In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following accelerated approval by the U.S. Food and Drug Administration in July 2020, Tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States. Tafasitamab, combined with Lenalidomide, has been approved, under accelerated approval, in US for adult patients with relapsed/refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). In August 2021, Health Canada and the European Commission and in October 2021, MHRA granted conditional Marketing Authorization for Minjuvi® (tafasitamab) in combination with Lenalidomide for the same indication (for details see Regulatory Highlights). There is a high-unmet medical need for this patient group.