New Chemotherapy-Free Immunotherapy Combination for Follicular Lymphoma Listed on the PBS
Rhea-AI Summary
Specialised Therapeutics announced that Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, is now listed on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 August 2026 for adults with relapsed or refractory follicular lymphoma (R/R FL, Grade 1–3a).
This is the first chemotherapy‑free, dual‑targeted CD19/CD20 immunotherapy regimen reimbursed on the PBS for these patients. The listing follows April 2026 TGA registration via Project Orbis and is enabled through Specialised Therapeutics’ exclusive 2021 distribution agreement with Incyte (NASDAQ: INCY) for Australia, New Zealand and Singapore.
In the Phase 3 inMIND trial, the Minjuvi combination reduced the risk of disease progression, relapse or death by 57% versus placebo plus rituximab and lenalidomide, with median progression‑free survival of 22.4 months vs 13.9 months (HR 0.43; P<0.0001). Safety was described as generally manageable but included high rates of infections and myelosuppression, requiring blood count monitoring and infection vigilance.
Positive
- PBS reimbursement in Australia for Minjuvi combo in R/R FL effective 1 August 2026
- First chemotherapy-free CD19/CD20 dual-targeted immunotherapy regimen funded on PBS for adult R/R FL
- inMIND Phase 3: 57% risk reduction in progression, relapse or death vs control
- Median PFS 22.4 vs 13.9 months with Minjuvi combo (HR 0.43; P<0.0001)
- 654 patients enrolled globally in inMIND, including 548 with R/R FL and 54 Australians
- Minjuvi/Monjuvi already has multiple approvals for FL and DLBCL in the US, Europe, Japan and Australia
Negative
- High infection rate: infections in 68% of patients; viral 41%, bacterial 27% in inMIND
- Myelosuppression: neutropenia 57%, thrombocytopenia 17%, anaemia 17% reported with Minjuvi combinations
- Serious adverse reactions: infections in 26% of patients; febrile neutropenia 2.8%, pyrexia 1.8%
- Treatment requires frequent blood count monitoring due to risk of serious or severe myelosuppression
News Explained
The Minjuvi combination is now PBS-listed effective
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 28 | Q2 earnings report | Positive | +9.3% | Revenue growth, raised guidance, and strong cash position supported the earnings update. |
| Jul 20 | Collaboration agreement | Positive | -1.4% | Halozyme collaboration added development and commercialization opportunities for INCA033989 formulations. |
| Jul 17 | Conference presentation | Neutral | +0.5% | Incyte scheduled multiple oncology data presentations at the ESMO Congress 2026. |
| Jul 13 | Clinical trial data | Positive | -2.1% | Phase 1/2 latarcibart data showed substantial bleeding reductions across von Willebrand disease types. |
| Jul 08 | Earnings date notice | Neutral | -0.7% | Incyte announced the July 28 release date for second-quarter financial results. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Incyte's historical reactions were mixed: positive earnings news preceded a 9.3% gain, while positive clinical data preceded a 2.12% decline.
Key Terms
progression-free survival medical
hazard ratio technical
PET-CR medical
myelosuppression medical
antibody-dependent cell-mediated cytotoxicity medical
antibody-dependent cellular phagocytosis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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).[1],[2]
- 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.[3] - 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.[4],[5]
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
"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
ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in
Minjuvi is a CD19 targeting immunotherapy that works within a patient's immune system to help find and eliminate malignant B-cells.[7] 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.[7]
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
"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
Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting.[7] Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.[7]
"Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community," said Sharon Winton, Chief Executive Officer of Lymphoma Australia. "As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families."
The PBS listing of Minjuvi for R/R FL means these patients will now have equitable access to a new targeted immunotherapy combination treatment when they need it. It is important that patients with R/R FL speak with their doctor to understand the most suitable treatment option available for them.
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:
This medicine is listed on the Pharmaceutical Benefits Scheme (PBS) — AUTHORITY REQUIRED. Refer to the PBS Schedule www.pbs.gov.au for full authority information.
Important Safety Information on Minjuvi[7]
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 (
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.
Ends.
About Minjuvi® (tafasitamab)
Minjuvi® (tafasitamab) is a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody. Minjuvi incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).[7] Incyte licenses exclusive worldwide rights to develop and commercialise Minjuvi from Xencor, Inc.
In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT.
Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorisation from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.
In Japan, Minjuvi is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory DLBCL. Minjuvi is also approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory FL (2L+ FL).
In
▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA.[7]
XmAb® is a registered trademark of Xencor, Inc.
Monjuvi and Minjuvi are registered trademarks of Incyte.
About the inMIND Study[3]
A global, double-blind, randomised, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years), including 548 participants with R/R FL. 54 Australians participated in the study across 12 local trial sites around the country.
The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population.
The clinical trial met its primary endpoint, with the data demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in comparison to placebo added to lenalidomide and rituximab. Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (
Minjuvi was generally well-tolerated, with a manageable safety profile. Safety and tolerability were comparable with the addition of Minjuvi to lenalidomide in combination with rituximab. The most common adverse reactions in the Phase 3 study (≥
About Specialised Therapeutics
Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas.
Additional information can be found at www.stbiopharma.com.
REFERENCES:
[1]. Australian Government, Department of Health, Disability and Ageing. PBS Schedule: PBS Publications & Downloads [August 2026]. |
[2]. NCCN Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. Version 3.2026. |
[3]. Sehn LH, et al. Lancet. 2026 Jan 10;407(10524):133-146. |
[4]. Lymphoma Australia. Types of Lymphoma: Follicular Lymphoma. [Accessed July 2026]. |
[5]. Australian Institute of Health and Welfare (AIHW). Cancer Data in |
[6]. Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG): MINJUVI (tafasitamab). [Accessed July 2026]. |
[7]. MINJUVI Australian Product Information. 20 April 2026. |
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