August 24, 2020
On August 3, 2020, the FDA granted accelerated approval to tafasitamab-cxix (Monjuvi; MorphoSys US) combined with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including those with DLBCL arising from low grade lymphoma and who are ineligible for autologous stem cell transplantation. This application was granted priority review, and given fast track, breakthrough, and orphan product designations.
The approval was based on efficacy data from the open-label, multi-center, single-arm L-MIND trial. In this study, 81 patients received tafasitamab-cxix 12 mg/kg intravenously with lenalidomide 25 mg orally (on days 1 to 25 of each 28-day cycle) for up to 12 cycles, followed by tafasitamab-cxix monotherapy.
The main efficacy end point was investigator-assessed overall response rate.
Findings showed that the best overall response rate was 55%, with complete responses in 37% of patients and partial responses in 18%. The median response duration was 21.7 months.
Neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite were the most frequently experienced adverse events.
US Food and Drug Administration. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. August 3, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma. Accessed August 3, 2020.