On July 31, 2020, the FDA accelerated the approval of tafasitamab-cxix (Monjuvi; Incyte/MorphoSys US), a CD19-directed cytolytic antibody, in combination with lenalidomide (Revlimid) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for autologous stem-cell transplant.
The FDA previously granted a breakthrough therapy designation for the combination of tafasitamab and lenalidomide for this indication.
“The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States,” said Professor Gilles Salles, MD, Chair of the Clinical Hematology Department, University of Lyon, France, and lead investigator of the L-MIND study. “Today’s FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy.”
The FDA approval of tafasitamab was based on the results of the phase 2 L-MIND study, an open-label, multicenter, single-arm clinical trial. The study included patients with relapsed or refractory DLBCL who received treatment with tafasitamab in combination with lenalidomide.
The primary end point was overall response rate (ORR). The ORR was 55%, including a 37% rate of complete response and an 18% partial response rate. The median duration of response was 21.7 months.
The most common (≥20%) adverse reactions were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.
For eligible patients who require financial assistance, Incyte and MorphoSys US offer a patient support program, My Mission Support.