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Tafasitamab in combination with rituximab and lenalidomide approved by the FDA for patients with R/R FL
On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved tafasitamab, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma (FL).1
This approval is based on results from the double-blind, placebo-controlled, phase III inMIND trial (NCT04680052), which were previously reported by the Lymphoma Hub.1 The primary endpoint was met, with a median progression-free survival of 22.4 months (95% confidence interval [CI]: 19.2 – not evaluable) in the tafasitamab + rituximab + lenalidomide arm compared with 13.9 months (95% CI: 11.5–16.4) in the placebo + rituximab + lenalidomide arm (hazard ratio [HR]: 0.43; 95% CI: 0.32–0.58; p < 0.0001).1
Tafasitamab + rituximab + lenalidomide is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with FL.1
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Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?
