Australia’s Therapeutic Goods Administration has approved a new three-drug combination—tafasitamab (Minjuvi) with rituximab and lenalidomide—for adults with relapsed or refractory follicular lymphoma, following a similar decision by the U.S. Food and Drug Administration in 2025.
The approval is based on a Phase 3 trial showing the combination significantly improved outcomes. Patients receiving the triplet therapy had a median progression-free survival of 22.4 months, compared with 13.9 months for standard treatment, cutting the risk of disease progression or death by 57%.
Common side effects included infections, low white blood cell counts, and viral infections, with serious cases mainly involving infections.
Experts say this offers an important new option, especially since about 20% of patients relapse early and often have limited treatment choices.