Minjuvi® (tafasitamab) Approved in Australia for Relapsed or Refractory Follicular Lymphoma
On April 23, 2026, Specialised Therapeutics announced that Minjuvi® (tafasitamab) has been registered by Australia’s Therapeutic Goods Administration (TGA) for the treatment of adult patients with relapsed or refractory follicular lymphoma (R/R FL), Grade 1-3a, following at least one prior line of systemic therapy. The approval is for use in combination with rituximab and lenalidomide, marking the first chemotherapy-free CD19 and CD20 dual-targeted immunotherapy regimen available in Australia for this patient population.
About Follicular Lymphoma and Treatment Needs
Follicular lymphoma is the second most common form of non-Hodgkin lymphoma, with approximately 1,500 Australians diagnosed annually. While many patients respond well to initial therapy, about one in five experience relapse within two years, often associated with poorer long-term outcomes. For those with relapsed or refractory disease, current treatments may not provide durable responses, underscoring the necessitate for effective, evidence-based options that can extend and improve quality of life.
Clinical Basis for Approval
The TGA’s decision is supported by data from the global Phase 3 inMIND trial (NCT04680052), a randomized, double-blind, placebo-controlled study that evaluated tafasitamab in combination with lenalidomide and rituximab versus placebo plus the same backbone in 548 adults with relapsed or refractory follicular lymphoma. Participants had received a median of one prior line of therapy, with 25% having undergone two prior lines and 20% having received three or more.
After a median follow-up of 14.1 months, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) for patients receiving tafasitamab. The hazard ratio was 0.43 (95% CI: 0.32–0.58; p < 0.0001), with median PFS estimated at 22.4 months in the tafasitamab arm compared to 13.9 months in the control group.
Serious adverse reactions occurred in 33% of patients in the tafasitamab group, including serious infections in 24%. The prescribing information includes warnings for infusion-related reactions, myelosuppression, and infections.
Regulatory Context and Global Availability
Minjuvi® is known as Monjuvi® in the United States, where tafasitamab-cxix received accelerated approval from the U.S. Food and Drug Administration (FDA) on June 18, 2025, for the same indication and combination regimen. The FDA approval was granted under Project Orbis, a collaborative initiative enabling concurrent review of oncology drugs among international regulators, including the Australian TGA and Health Canada.
In the European Union, the medicine is authorized as Minjuvi for follicular lymphoma in patients whose disease has relapsed or failed to respond after at least one prior treatment, also administered with lenalidomide and rituximab.
Significance of the Australian Approval
The TGA registration makes Minjuvi the first and only chemotherapy-free dual-targeted immunotherapy combination approved in Australia for adults with relapsed or refractory follicular lymphoma (Grades 1-3a). By targeting both CD19 and CD20 antigens, tafasitamab offers a distinct mechanism of action aimed at improving outcomes for patients who have exhausted conventional options.
As noted by Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead at Concord Repatriation General Hospital in Sydney, the approval addresses a critical unmet need: “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. 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.”
Conclusion
The approval of Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide represents a significant advancement in the treatment landscape for relapsed or refractory follicular lymphoma in Australia. By providing a chemotherapy-free immunotherapy option with demonstrated efficacy in prolonging progression-free survival, the regimen offers novel hope for patients facing limited therapeutic choices after relapse.