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FDA approves tafasitamab in combination with lenalidomide as second-line treatment for patients with R/R DLBCL

Aug 4, 2020
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On July 31, 2020, the U.S. Food and Drug Administration (FDA) approved tafasitamab in combination with lenalidomide as second-line treatment for adult patients with relapsed or refractory (R/R) 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 (ASCT).1

Tafasitamab, is an anti-CD19 monoclonal antibody, and in combination with lenalidomide has previously obtained FDA breakthrough therapy and priority review designations for R/R DLBCL. The approval was based on the results from the open-label, multicenter, single arm, phase II L-MIND trial (NCT02399085). This trial evaluated tafasitamab in combination with lenalidomide in adult patients with R/R DLBCL, who had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), and who were not eligible for high-dose chemotherapy or refused subsequent ASCT. Results from this study, showed2:

  • Overall response rate: 55% (primary endpoint)
  • Complete response rate: 37%
  • Partial response rate: 18%
  • Median duration of response: 21.7 months (key secondary endpoint)

Possible side effects of tafasitamab included2:

  • Infusion-related reactions, 6%
  • Serious or severe myelosuppression:
    • Neutropenia, 50%
    • Thrombocytopenia, 18%
    • Anemia, 7%
  • Infections (73%)

The most common adverse reactions (≥ 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.2

The FDA decision represents the first approval of a second-line treatment for adult patients with R/R DLBCL. The European Medicines Agency (EMA) has recently validated a marketing authorization application for tafasitamab in combination with lenalidomide in the EU, and the submission is currently under review for the treatment of adult patients with R/R DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.2

Tafasitamab is under investigation as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

  1. FDA. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma. Published Aug 03, 2020. Accessed Aug 03, 2020.
  2. BusinessWire. FDA approves Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). https://www.businesswire.com/news/home/20200731005497/en/FDA-Approves-Monjuvi%C2%AE-tafasitamab-cxix-Combination-Lenalidomide-Treatment. Published Jul 31, 2020. Accessed Aug 03, 2020.

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