Australia's Therapeutic Goods Administration has registered MINJUVI (tafasitamab) in combination with rituximab and lenalidomide for treating adults with relapsed or refractory follicular lymphoma, according to Specialised Therapeutics.

The approval makes MINJUVI the first chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen approved in Australia for this patient population. Follicular lymphoma represents the second most common form of non-Hodgkin lymphoma, with approximately 1,500 Australians diagnosed annually.

The registration was based on results from the global Phase 3 inMIND clinical study, which evaluated 652 patients including 548 participants with relapsed or refractory follicular lymphoma. The study included 54 Australian participants across 12 local trial sites.

In the clinical trial, patients receiving the MINJUVI combination achieved a median progression-free survival of 22.4 months compared to 13.9 months for patients receiving placebo with lenalidomide and rituximab. This represented a 57% reduction in the risk of disease progression, relapse or death.

The most common adverse reactions in patients receiving MINJUVI included respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough. The drug was generally well-tolerated with a manageable safety profile.

Specialised Therapeutics entered into an exclusive distribution agreement with Incyte (NASDAQ: INCY) in 2021 to commercialize MINJUVI in Australia, New Zealand and Singapore.

The drug is not currently listed on Australia's Pharmaceutical Benefits Scheme. Specialised Therapeutics stated it will work with the Pharmaceutical Benefits Advisory Committee and Department of Health, Disability and Ageing to enable access for eligible patients.