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Tafasitamab + rituximab + lenalidomide approved by Australia’s TGA for R/R FL

By Amy Hopkins

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Apr 23, 2026

Learning objective: After reading this article, learners will be able to cite a new clinical development in follicular lymphoma.


On April 23, 2026, Australia’s Therapeutic Goods Administration approved tafasitamab, a CD19 targeted monoclonal antibody, in combination with rituximab + lenalidomide for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL).1

Approval was based on results from the phase III inMIND (NCT04680052) study, evaluating tafasitamab + rituximab + lenalidomide vs placebo + rituximab + lenalidomide in patients with R/R FL.1,2 Patients receiving the tafasitamab combination had a longer median progression-free survival (PFS) compared with patients receiving the placebo combination (22.4 months vs 13.9 months; p < 0.0001).2 The best overall response rate was 84% with the addition of tafasitamab vs 72% without (p = 0.0014).2 The incidence of adverse events was similar between groups.2 A full analysis of overall survival is planned at 5 years of follow-up.2 

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