New Chemotherapy-Free Immunotherapy Combination for Follicular Lymphoma Listed on the PBS

Minjuvi ® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen listed on the Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a). In the pivotal Phase 3 inMIND clinical trial, patients with R/R FL receiving the Minjuvi combination regimen experienced a significant improvement in progression-free survival, with a 57% reduction in the risk of disease progression, relapse or death, compared with placebo plus lenalidomide and rituximab. Follicular lymphoma is the second most common non-Hodgkin lymphoma (NHL), with over 10,000 Australians living with the disease and approximately 1,500 Australians diagnosed each year. Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the listing of Minjuvi ® (tafasitamab), in combination with rituximab and lenalidomide, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a). This milestone follows the Australian registration of Minjuvi for R/R FL by the Therapeutic Goods Administration (TGA) in April 2026, via the Project Orbis process. The PBS listing of Minjuvi marks the availability of the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this group of patients. Effective 1 August 2026, eligible patients with FL who have experienced relapses or disease progression on existing therapies will now have equitable access to a new treatment option for this difficult-to-treat condition. As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia, said Carlo Montagner, ST Chief Executive Officer. After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay. ST entered into an exclusive distribution agreement with Incyte (NASDAQ: INCY ) in 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore. Minjuvi is a CD19 targeting immunotherapy that works within a patient's immune system to help find and eliminate malignant B-cells. In combination with rituximab and lenalidomide, Minjuvi delivers a complementary immune-mediated approach that helps control disease progression and supports improved long-term outcomes for patients with follicular lymphoma. The PBS reimbursement underscores the growing recognition of innovative immunotherapy-based treatment strategies in follicular lymphoma and reinforces ST's commitment to improving access to life-changing therapies for patients across the Asia-Pacific region. While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment, said Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne. Today's PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for R/R FL. Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting. Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituxima...