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Tafasitamab in combination with lenalidomide approved by China’s National Medical Products Administration for adult patients with R/R DLBCL
On May 21, 2025, China’s National Medical Products Administration (NMPA) granted approval for tafasitamab, a CD19-targeting monoclonal antibody, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT).1 Tafasitamab plus lenalidomide was previously approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the same indication.1
This approval was based on results from Chinese clinical studies of this combination, which showed similar results to the global L-MIND study (NCT02399085).1 It is the first CD19 antibody approved for the treatment of R/R DLBCL in China.
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In your experience, what is the average time to secure a reimbursed CAR T-cell therapy manufacturing slot for patients with DLBCL (from decision to treatment with a CAR T-cell therapy)?
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