Australia approves Minjuvi as first chemotherapy-free immunotherapy for follicular lymphoma

Independent biopharmaceutical company Specialised Therapeutics has announced that the Therapeutic Goods Administration (TGA) has registered Minjuvi (tafasitamab) for use in Australia.

 The drug, in combination with rituximab and lenalidomide, is now approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grade 1-3a), News.Az reports, citing PR News Wire.

This milestone establishes Minjuvi as the first and only chemotherapy-free, dual-targeted immunotherapy regimen targeting both CD19 and CD20 approved in the country for this patient group.

The approval is supported by data from the Phase 3 inMIND clinical trial, which demonstrated a statistically significant improvement in median progression-free survival—22.4 months for those on the Minjuvi regimen compared to 13.9 months in the control group. Experts noted that the registration aligns Australian clinical practice with global standards, addressing a critical need for therapies that lower the risk of disease progression in patients whose cancer has returned or failed to respond to previous treatments.

News.Az 

By Leyla Şirinova