Tafasitamab: First Approval

Tafasitamab (tafasitamab-cxix; MONJUVI(R)) is an Fc-modified (i.e. two amino acid substitutions within the Fc region, resulting in increased Fc gamma receptor affinity), humanized, anti-CD19 monoclonal antibody. Developed by MorphoSys AG, under a license from Xencor, it received accelerated approval (in July 2020) for use in combination with lenalidomide as a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). It is the first therapy to be approved as a second-line treatment for this patient population in the USA. The recommended dose of tafasitamab is 12 mg per kg of bodyweight, administered via an intravenous infusion. A regulatory assessment for tafasitamab plus lenalidomide for the treatment of adults with relapsed or refractory DLBCL is currently underway in the EU. Tafasitamab is also being clinically investigated as a therapeutic option in various other B-cell malignancies, including follicular lymphoma and other indolent non-Hodgkin's lymphoma. This article summarizes the milestones in the development of tafasitamab leading to this first approval for its use in combination with lenalidomide in adults with relapsed or refractory DLBCL.