Singapore, August 2, 2026
Specialised Therapeutics (ST) announced that Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, has been listed on Australia’s Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL), Grade 1-3a. Effective August 1, 2026, the reimbursement milestone provides eligible Australian patients with subsidised access to what the company describes as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this patient population. The PBS listing follows Australian registration of Minjuvi for R/R follicular lymphoma by the Therapeutic Goods Administration (TGA) in April 2026 through Project Orbis, marking an important regulatory and patient-access milestone for the therapy.
PBS Listing Expands Access to Chemotherapy-Free Treatment
The new PBS reimbursement means eligible patients whose follicular lymphoma has relapsed or progressed following existing therapies can access a new targeted immunotherapy option with government subsidy. According to Specialised Therapeutics, Minjuvi is the first new therapy to receive PBS reimbursement for R/R follicular lymphoma in nine years. Follicular lymphoma is the second most common type of non-Hodgkin lymphoma, with more than 10,000 Australians living with the disease and approximately 1,500 people diagnosed annually. Although follicular lymphoma is often slow growing and may initially respond to treatment, many patients experience repeated relapses and require multiple lines of therapy over their lifetime. The Minjuvi regimen provides an alternative treatment strategy that does not rely on traditional chemotherapy. Minjuvi is a CD19-targeting immunotherapy designed to work with the patient’s immune system to identify and eliminate malignant B cells. When combined with the CD20-targeting rituximab and immunomodulatory agent lenalidomide, the regimen provides complementary immune-mediated mechanisms intended to control disease progression.
Phase 3 inMIND Trial Demonstrates Improved Progression-Free Survival
The PBS listing is supported by findings from the pivotal Phase 3 inMIND clinical trial, a global, double-blind, randomised and placebo-controlled study evaluating tafasitamab in combination with rituximab and lenalidomide. The study enrolled 654 adults, including 548 patients with relapsed or refractory follicular lymphoma, with 54 Australian participants enrolled across 12 local clinical trial sites. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful improvement in progression-free survival. Patients receiving the Minjuvi combination achieved a median investigator-assessed progression-free survival of 22.4 months compared with 13.9 months in the control group, corresponding to a hazard ratio of 0.43. This represented a 57% reduction in the risk of disease progression, relapse or death compared with placebo plus lenalidomide and rituximab. Independent Review Committee assessment was consistent with the investigator-based findings. The regimen was reported to have a manageable safety profile, with common adverse reactions including infections, neutropenia, rash and asthenia. Patients receiving treatment require appropriate clinical monitoring, including blood counts and monitoring for infections.
Advertisement
Minjuvi Strengthens Targeted Immunotherapy Options in Lymphoma
Minjuvi is a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody incorporating an engineered Fc domain designed to promote B-cell elimination through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis. For Australian patients with R/R follicular lymphoma, Minjuvi is administered through intravenous infusion in a clinic or hospital, with patients receiving up to 12 treatment cycles alongside oral lenalidomide, while rituximab is administered intravenously during the first five cycles. The Australian reimbursement milestone follows broader international regulatory progress for tafasitamab, including approvals for follicular lymphoma in other major markets. Specialised Therapeutics has held an exclusive agreement with Incyte since 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore. The combination of TGA registration, Phase 3 clinical evidence and PBS reimbursement represents a significant step toward expanding access to targeted, chemotherapy-free immunotherapy for Australians living with relapsed or refractory follicular lymphoma and highlights the continued evolution of treatment strategies for B-cell malignancies.
Source: Specialised Therapeutics press release
