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FDA Approvals, News & UpdatesLymphoma

FDA Approves Monjuvi for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

In July 2020, the FDA approved Monjuvi as a new treatment option for patients with diffuse large B-cell lymphoma whose disease progressed after receiving other therapies.
October 2020 Vol 6 No 5

In July 2020, the FDA approved Monjuvi (tafasitamab-cxix; from Incyte and MorphoSys US), a CD19-directed antibody, for use in combination with Revlimid (lenalidomide), for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL for short) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for a transplant.

“Today’s FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy,” said Professor Gilles Salles, MD, Chair of the Clinical Hematology Department, University of Lyon, France.

The FDA approval of Monjuvi was based on the results of a phase 2, open-label, multicenter, single-arm clinical trial. All patients in the study had relapsed or refractory DLBCL and received treatment with Monjuvi, in combination with Revlimid.

Overall, 55% of the patients responded to treatment with the drug combination, including 37% of patients who had a complete response (no sign of cancer) and 18% of patients who had a partial response. The average duration of response was 21.7 months.

The most common side effects reported with Monjuvi were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, fever, swelling (edema), respiratory tract infection, and decreased appetite.

For eligible patients who need financial assistance, Incyte and MorphoSys US offer a patient support program called My Mission Support.

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Last modified: November 17, 2020

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