U.S. Food and Drug Administration Approves Tafasitamab-cxix (MONJUVI) for Diffuse Large B-cell Lymphoma (DLBCL)

 On July 31, 2020 the U.S. Food and Drug Administration (FDA) announced it has approved tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, in combination with lenalidomide (REVLIMID) for adult patients 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 transplant.

“The approval of tafasitamab-cxix illustrates the significant progress made in understanding diffuse large B-cell lymphoma,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “Diffuse large B-cell lymphoma is the most common type of lymphoma; however, relapsed or refractory disease remains a significant area of unmet need. This approval offers patients a new treatment option and new hope for improving outcomes.”

For more information on the FDA approval of tafasitamab-cxix (MONJUVI), visit the FDA’s website or lymphoma.org/DLBCLFDAUpdates.