Specialised Therapeutics (ST), a Singapore-headquartered specialty pharmaceutical company, announced in a press release on August 2 that Minjuvi (tafasitamab), used together with rituximab and lenalidomide, is now reimbursed under Australia’s Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL). For patients, the listing means government-subsidized access to a chemotherapy-free treatment option. For investors, it is another step in the international rollout of tafasitamab, an antibody for which Incyte Corporation (NASDAQ: INCY) holds exclusive worldwide development and commercialization rights, licensed from Xencor, Inc. ST has held an exclusive distribution agreement with Incyte since 2021 to commercialize the drug across Australia, New Zealand, and Singapore.
A Funding Decision, Not a New Approval
The PBS listing, effective August 1, 2026, is a reimbursement decision, not a new regulatory approval. It follows the drug’s registration for R/R FL by Australia’s Therapeutic Goods Administration (TGA) in April 2026, granted through Project Orbis, a framework that lets regulators in several countries review a therapy in parallel. In Australia’s health system, a drug can be TGA-approved and still be unaffordable for most patients until it is separately listed on the PBS, the program through which the federal government subsidizes the cost. According to ST, this is the first new therapy added to the PBS for R/R FL in nine years, and the listing carries an “Authority Required” designation, meaning doctors must meet specific criteria before prescribing it rather than it being available to any patient on request.
What the Underlying Trial Data Showed
The reimbursement decision rests on results from inMIND, a global, double-blind, randomized, placebo-controlled Phase 3 trial (NCT04680052) that enrolled 654 adults, including 548 with R/R FL, with 54 Australian participants across 12 local sites. The trial’s primary endpoint, progression-free survival (PFS) by investigator assessment in the FL population, was met: patients on the tafasitamab combination had a median PFS of 22.4 months versus 13.9 months for those on placebo plus lenalidomide and rituximab, a 57% relative reduction in the risk of disease progression, relapse, or death (hazard ratio 0.43; 95% CI, 0.32–0.58; P<0.0001). An independent review committee’s assessment was broadly consistent with the investigator analysis. The results were published in The Lancet in January 2026, meaning the data has been through peer review rather than only appearing in company materials.
Safety Profile
Per the Australian product information cited in the release, the most common adverse reactions in the Phase 3 study included infections (68%, including viral and bacterial infections), neutropenia (57%), rash, fatigue, low platelet and red blood cell counts, infusion-related reactions, itching, and headache. Serious adverse reactions included infections and febrile neutropenia. The label warns that tafasitamab can cause serious myelosuppression and calls for regular blood count monitoring, and that treatment should not start in an uncontrolled active infection or in female patients without first ruling out pregnancy. This is label and trial safety information, not medical guidance; patients and caregivers should direct treatment questions to a qualified healthcare professional.
Where Tafasitamab Stands Globally
The Australian FL listing adds to a patchwork of approvals Incyte has been building out market by market. In the United States, the drug (marketed as Monjuvi) is FDA-approved in combination with lenalidomide and rituximab for R/R FL, and separately holds accelerated approval in combination with lenalidomide for certain R/R diffuse large B-cell lymphoma (DLBCL) patients. In Europe, Minjuvi has conditional marketing authorization for R/R DLBCL, and the European Medicines Agency approved the FL combination in December 2025. Japan has approved both the DLBCL and FL combinations. In Australia specifically, the drug was previously indicated only for R/R DLBCL; the April 2026 TGA registration and this PBS listing extend that to R/R FL. The company’s press release does not disclose pricing, sales figures, or revenue guidance tied to the Australian listing, and none is estimated here.
Broader Market Context
Follicular lymphoma is the second most common form of non-Hodgkin lymphoma, with more than 10,000 Australians currently living with the disease and roughly 1,500 new diagnoses each year, according to figures from Lymphoma Australia and the Australian Institute of Health and Welfare cited in the release. More broadly, chemotherapy-free, antibody-based combinations targeting multiple B-cell surface markers such as CD19 and CD20 reflect a wider industry shift in lymphoma treatment away from chemotherapy-anchored regimens, a trend playing out across several companies’ pipelines rather than something unique to this announcement.
What’s Next
Associate Professor Philip Thompson, a clinical haematologist at Melbourne’s Peter MacCallum Cancer Centre and Royal Melbourne Hospital, said the listing gives Australian clinicians “a new, chemotherapy-free immunotherapy treatment for R/R FL,” while Lymphoma Australia CEO Sharon Winton called funded access to the regimen “deeply meaningful” for patients managing recurring disease. Under the funded regimen, patients receive up to 12 cycles of intravenous Minjuvi alongside oral lenalidomide, with rituximab given intravenously for the first five cycles. ST is privately held and does not trade under a stock ticker; Incyte, its commercial partner for the Australian market, is publicly traded in the United States. This article covers a regulatory reimbursement and clinical-trial development, not an investment recommendation.
Sources
Specialised Therapeutics: New Chemotherapy-Free Immunotherapy Combination for Follicular Lymphoma Listed on the PBS, PRNewswire, August 2, 2026.
Editorial Disclosure
This article is based on a press release issued by Specialised Therapeutics on August 2, 2026, distributed via PRNewswire. Specialised Therapeutics is a privately held company and does not trade under a stock ticker; its commercial partner for this market, Incyte Corporation, trades on Nasdaq under the ticker INCY. BioTech Stocks Daily was not compensated for this coverage. Statements regarding clinical, regulatory, or commercial outcomes are based on trial results and regulatory actions already reported in the source release; where figures reflect trial or company data, they are attributed accordingly. This article is for informational and educational purposes only, does not constitute investment advice, and is not medical advice. Consult a qualified healthcare professional for medical guidance. See our full Disclaimer.
