FDA approves tafasitamab-cxix for R/R DLBCL

  • FDA
  • 31 Jul 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • The US Food and Drug Administration (FDA) has granted accelerated approval to tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
  • The recommended dose is 12 mg/kg as an intravenous infusion.

Why this matters

  • Tafasitamab-cxix with lenalidomide is the first treatment approved by the FDA for second-line use in patients with R/R DLBCL.

Key points

  • The approval is based on data from the single-arm phase 2 L-MIND trial. 
  • 81 patients with R/R DLBCL who had previously received at least 1 but not more than 3 lines of treatment received tafasitamab-cxix with lenalidomide for a maximum of 12 cycles, followed by tafasitamab-cxix monotherapy.
  • The best overall response rate in 71 patients with DLBCL confirmed by central pathology was 55% (complete responses in 37% and partial responses in 18%). 
  • The median response duration was 21.7 (range, 0-24) months.
  • The most common adverse reactions (20%) included neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, fever, peripheral edema, respiratory tract infection, and decreased appetite.
  • Warnings and precautions include infusion-related reactions, serious or severe myelosuppression, infections, and embryo-fetal toxicity.

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