On April 23, 2026 Independent biopharmaceutical company Specialised Therapeutics (ST) reported that Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, has been registered by the Therapeutic Goods Administration (TGA) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).1
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The TGA registration establishes Minjuvi as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for this group of patients.2
"While most patients with follicular lymphoma respond well to initial treatment and patients’ prognosis has improved, around one in five will see their lymphoma return within two years, which is often linked to poorer long-term outcomes," said Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead in the Haematology Department at Concord Repatriation General Hospital in Sydney. "For these patients, current therapies do not always deliver durable responses, highlighting the urgent need for evidence-based options that can meaningfully extend and improve their lives."
Follicular Lymphoma (FL) is the second most common form of non-Hodgkin Lymphoma (NHL), accounting for 20-30% of all NHL cases.4 An estimated 1,500 Australians are newly diagnosed with FL each year.5
"The TGA registration of Minjuvi marks an important new advance for patients with relapsed or refractory follicular lymphoma, bringing Australian clinical practice in line with accepted global standards of care," said Professor Trotman.
The TGA registration of Minjuvi in combination with rituximab and lenalidomide in R/R FL was based on the results from the global Phase 3 inMIND clinical study. This trial evaluated the efficacy and safety of the regimen in 652 patients, including 548 participants with R/R FL. Notably, 54 Australians participated across 12 local trial sites across the country.6
In the clinical trial, patients receiving the Minjuvi combination regimen achieved a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) of 22.4 months (compared to 13.9 months in patients receiving placebo added to lenalidomide and rituximab) — representing a 57% reduction in the risk of disease progression, relapse or death.6
Minjuvi was generally well-tolerated, with a manageable safety profile.6 The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.6
In 2021, ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) to commercialise Minjuvi in Australia, New Zealand and Singapore.
"Follicular lymphoma is an incurable blood cancer and treatment options after relapse remain limited, with each recurrence more challenging to find effective treatments," said Carlo Montagner, ST Chief Executive Officer. "We are extremely proud to bring the first and only chemotherapy-free treatment option to eligible Australians with relapsed or refractory follicular lymphoma, addressing a critical need for new therapies that may lower the risk of disease progression, relapse or death."
"The Minjuvi approval represents the ninth time ST has successfully navigated the Project Orbis process since 2021," said Mr Montagner. "With TGA registration secured, we are committed to working with the Pharmaceutical Benefits Advisory Committee and Department of Health, Disability and Ageing to enable equitable access to Minjuvi for Australians with relapsed or refractory follicular lymphoma as soon as possible."
For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.
PBS Information: Minjuvi is not listed on the Pharmaceutical Benefits Scheme (PBS).
Important safety Information on Minjuvi7
Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops. Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded.
In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).
Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.
(Press release, Specialised Therapeutics Australia, APR 23, 2026, View Source [SID1234664733])