(tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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MONJUVI is second-line targeted immunotherapy for adult patients with DLBCL who are ineligible for transplant1*

1-year primary analysis in patients with R/R DLBCL (N=71)1

  • Best ORR: 55% (n=39; 95% CI: 43%, 67%); CR: 37%; PR: 18%
  • Median DoR 21.7 months (range: 0, 24)‡

L-MIND was an open-label, multicenter, single-arm, phase 2 study that evaluated the efficacy and safety of MONJUVI in combination with lenalidomide followed by MONJUVI monotherapy in adult patients with R/R DLBCL (confirmed by central laboratory) who were not eligible for or refused ASCT. Efficacy was established in 71 patients based on best ORR (CR + PR) and DoR, as assessed by an Independent Review Committee using the International Working Group Response Criteria (Cheson 2007).1,2

*MONJUVI is a CD19-directed cytolytic monoclonal antibody.1

†Assessed by an Independent Review Committee.1

‡Kaplan-Meier estimates.1

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