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.

Share this:

Recommended For You
FDA Approvals, News & UpdatesMultiple Myeloma
Blenrep Approved for the Treatment of Relapsed or Refractory Multiple Myeloma
Adrug called Blenrep (belantamab mafodotin-blmf) was recently approved by the Food and Drug Administration (FDA) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies (including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent).
FDA Approvals, News & UpdatesLeukemia
Imbruvica/Rituximab Combo Approved for First-Line Leukemia
The Food and Drug Administration (FDA) has expanded the use of the anticancer drug Imbruvica (ibrutinib) to be used in combination with rituximab for the treatment of the most common type of leukemia in adults, chronic lymphocytic leukemia (CLL), or its variant called small lymphocytic lymphoma (SLL).
Last modified: November 17, 2020

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.