MorphoSys and Incyte have announced that tafasitamab-cxix, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines® (NCCN Guidelines®) in Oncology for B-Cell Lymphomas. Specifically, the NCCN Guidelines in the United States now include tafasitamab-cxix in combination with lenalidomide with a category 2A designation as an option for the treatment of previously treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including those with DLBCL arising from low-grade lymphoma who are ineligible for autologous stem cell transplant (ASCT).
“We are very gratified the NCCN acted quickly to include Monjuvi [tafasitamab-cxix] in combination with lenalidomide with a category 2A designation in its Clinical Practice Guidelines in Oncology as a treatment for patients with relapsed or refractory DLBCL who are not candidates for transplant. This targeted therapeutic option helps address an immediate medical need for patients who previously had limited treatment options,” said Malte Peters, MD, Chief Research and Development Officer, MorphoSys. “There is no other FDA [U.S. Food and Drug Administration]-approved second-line treatment for these patients with a 2A designation within the NCCN Guidelines.”
Malte Peters, MD
The FDA approved tafasitamab-cxix in combination with lenalidomide under accelerated approval on July 31, 2020, for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DBLCL arising from low-grade lymphoma, and who are not eligible for ASCT. The approval was based on data from the phase II L-MIND study, an open-label, multicenter, single-arm trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.