FDA Approves Tafasitamab Plus Lenalidomide in Relapsed/Refractory DLBCL

The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of 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.

“We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials,” said Jean-Paul Kress, MD, chief executive officer, at MorphoSys, stated in a press release. “This approval marks an important step in MorphoSys’ transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases.”

The regulatory approval was based on data from the open-label, multicenter, single-arm phase 2 L-MIND study, an open label, which examined tafasitamab-cxix in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.

Results showed an overall response rate (ORR) of 55%, which included a complete response (CR) rate of 37% and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months.

The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of tafasitamab-cxix and lenalidomide in relapsed or refractory DLBCL.