The Therapeutic Goods Administration (TGA) has approved tafasitamab (MINJUVI®) in combination with lenalidomide and rituximab for adult Australian patients with relapsed or refractory follicular lymphoma (FL) grade 1-3a after at least one prior systemic therapy, according to a press release by Specialised Therapeutics, an independent specialty pharmaceutical company in the region that distributes therapies.
The regulatory approval is based on the results from the phase 3 inMIND clinical trial and follows similar approvals by the European Commission and the US FDA, which approved the therapy in June 2025.
The phase 3 inMIND trial evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide in 548 adult patients with relapsed or refractory follicular lymphoma. The trial showed that the treatment reached its primary endpoint and that the treatment was well tolerated, with a manageable safety profile.
Tafasitamab is a CD19-directed cytolytic antibody; Incyte licenses exclusive worldwide rights to develop and commercialise tafasitamab from the clinical-stage biopharmaceutical company Xencor, Inc.
