MINJUVI® (tafasitamab) for Relapsed or Refractory Follicular Lymphoma Approved in Australia

Rhea-AI Summary

Specialised Therapeutics announced TGA registration of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma (Grade 1-3a) in Australia.

The approval makes Minjuvi the first chemotherapy-free CD19/CD20 dual-targeted immunotherapy regimen in Australia; Phase 3 inMIND (652 patients; 548 R/R FL) showed median PFS 22.4 months versus 13.9 months (57% risk reduction). PBS listing is not yet in place.

Positive

• TGA registration of Minjuvi combination for R/R follicular lymphoma in Australia
• First chemotherapy-free CD19/CD20 dual-targeted regimen approved in Australia
• Phase 3 inMIND: median PFS 22.4 months vs 13.9 months (57% risk reduction)
• Clinical dataset included 652 patients with 548 R/R FL participants; 54 Australians enrolled

Negative

• Minjuvi is not listed on the Pharmaceutical Benefits Scheme (PBS)
• InMIND reported common serious infections (26%) as adverse reactions
• Treatment can cause severe myelosuppression; requires regular complete blood count monitoring

News Market Reaction – INCY

-1.31%

-1.31% Session close to close

In the Apr 23 session, INCY declined 1.31%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights TGA approval of Minjuvi for relapsed or refractory follicular lymphoma ...

Analysis

This announcement highlights TGA approval of Minjuvi for relapsed or refractory follicular lymphoma based on Phase 3 inMIND data showing median PFS of 22.4 months versus 13.9 months and a 57% risk reduction. It extends tafasitamab’s footprint into a chemotherapy-free regimen and builds on prior lymphoma progress. Investors may track real-world uptake in Australia, evolving safety experience, and how this indication fits alongside other recent approvals in INCY’s oncology portfolio.

Key Figures

Annual FL cases Australia: 1,500 patients FL share of NHL: 20–30% inMIND total patients: 652 patients +5 more

8 metrics

Annual FL cases Australia 1,500 patients Estimated newly diagnosed follicular lymphoma cases per year in Australia

FL share of NHL 20–30% Proportion of non-Hodgkin lymphoma cases that are follicular lymphoma

inMIND total patients 652 patients Global Phase 3 inMIND trial population

R/R FL patients 548 patients Participants with relapsed or refractory follicular lymphoma in inMIND

Australian participants 54 patients Australians enrolled across 12 trial sites in inMIND

Median PFS Minjuvi combo 22.4 months Progression-free survival with Minjuvi + rituximab + lenalidomide

Median PFS control 13.9 months Progression-free survival with placebo + rituximab + lenalidomide

Risk reduction PFS 57% Reduction in risk of progression, relapse or death vs control

Historical Context

5 past events · Latest: Apr 21 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 21	Clinical data update	Positive	-0.7%	Positive Phase 3 frontMIND tafasitamab data slated for ASCO oral presentation.
Apr 09	Earnings date notice	Neutral	+1.1%	Announcement of schedule for Q1 2026 financial results and conference call.
Mar 25	Leadership changes	Positive	+1.8%	Executive appointments to strengthen R&D and late-stage development leadership structure.
Mar 20	Dermatology data	Positive	-2.3%	Late-breaking 54-week Phase 3 povorcitinib data and ruxolitinib cream presentations at AAD.
Mar 06	EU drug approval	Positive	+1.2%	European Commission approval of Zynyz plus chemotherapy for first-line SCAC treatment.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive regulatory and clinical updates have produced mixed reactions, with several instances where favorable data or approvals coincided with short-term share price declines.

Recent Company History

Over recent months, INCY has reported multiple pipeline and regulatory milestones, including European Commission approval of Zynyz for SCAC on Mar 6 and late-breaking hidradenitis suppurativa data on Mar 20. Leadership changes were announced on Mar 25, and new Phase 3 tafasitamab data for DLBCL were highlighted on Apr 21. Market reactions have alternated between gains and pullbacks, suggesting that even positive oncology updates, like today’s Australian Minjuvi approval, have not always translated into consistent upside.

Key Terms

cd19, cd20, immunotherapy, therapeutic goods administration, +4 more

8 terms

cd19 medical

"chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen"

CD19 is a protein found on the surface of most B cells, a type of immune cell; think of it as a distinctive nametag that helps identify and track these cells. It matters to investors because many cancer and autoimmune treatments, diagnostics, and lab tests are designed to target or detect CD19—so advances, approvals, or setbacks in CD19‑focused therapies can directly affect drug pipelines, regulatory value, and potential revenue for healthcare companies.

cd20 medical

"chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen"

CD20 is a protein that sits on the surface of a subset of white blood cells called B cells, acting like a nametag that lets medicines and tests recognize those cells. It matters to investors because many treatments and diagnostics are built to seek out that nametag, so drugs that bind CD20 can drive clinical trial value, regulatory outcomes and sales potential, while changes in safety or effectiveness can materially affect a company’s prospects.

immunotherapy medical

"dual-targeted immunotherapy combination regimen to be approved in Australia"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

therapeutic goods administration regulatory

"has been registered by the Therapeutic Goods Administration (TGA) for the treatment"

The Therapeutic Goods Administration is the Australian government agency that assesses and regulates medicines, medical devices, vaccines and other health products for safety, quality and effectiveness before they can be marketed. For investors, a TGA decision is like a building inspector’s sign-off: approval opens access to the Australian market and can unlock sales and valuation, while delays, restrictions or safety warnings can limit revenue, force product changes or raise compliance and legal costs.

phase 3 medical

"based on the results from the global Phase 3 inMIND clinical study"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

progression-free survival medical

"improvement in median progression-free survival (PFS) of 22.4 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

project orbis regulatory

"approval represents the ninth time ST has successfully navigated the Project Orbis process"

Project Orbis is a global regulatory initiative that lets multiple national drug agencies review cancer drug applications together so companies can seek faster, coordinated approvals across several countries at the same time. Think of it as arranging several building inspectors to evaluate the same project in parallel rather than one after another; for investors, it can shorten time to market, reduce approval uncertainty, and accelerate potential revenue and licensing opportunities.

myelosuppression medical

"tafasitamab can cause serious or severe myelosuppression including neutropenia"

A condition where the bone marrow slows or stops making blood cells, causing low white cells (higher infection risk), red cells (fatigue, oxygen problems), or platelets (bleeding risk). Think of the marrow as a factory that supplies vital workers; when it falters, patients become vulnerable. For investors, myelosuppression matters because it can limit a drug’s safety, change dosing or monitoring needs, affect regulatory approval and label warnings, and influence commercial potential and costs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Minjuvi^® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).^1,2
• Despite the availability of existing treatments, R/R FL remains incurable, is characterised by repeated relapses and typically has a poor prognosis.³
• Follicular lymphoma is the second most common form of non-Hodgkin lymphoma, with 1,500 Australians newly diagnosed each year.^4,5

SINGAPORE, April 23, 2026 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce that Minjuvi^® (tafasitamab), in combination with rituximab and lenalidomide, has been registered by the Therapeutic Goods Administration (TGA) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).¹

The TGA registration establishes Minjuvi as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for this group of patients.²

"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," said Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead in the Haematology Department at Concord Repatriation General Hospital in Sydney. "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."

Follicular Lymphoma (FL) is the second most common form of non-Hodgkin Lymphoma (NHL), accounting for 20-30% of all NHL cases.⁴ An estimated 1,500 Australians are newly diagnosed with FL each year.⁵

"The TGA registration of Minjuvi marks an important new advance for patients with relapsed or refractory follicular lymphoma, bringing Australian clinical practice in line with accepted global standards of care," said Professor Trotman.

The TGA registration of Minjuvi in combination with rituximab and lenalidomide in R/R FL was based on the results from the global Phase 3 inMIND clinical study. This trial evaluated the efficacy and safety of the regimen in 652 patients, including 548 participants with R/R FL. Notably, 54 Australians participated across 12 local trial sites across the country.⁶

In the clinical trial, patients receiving the Minjuvi combination regimen achieved a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) of 22.4 months (compared to 13.9 months in patients receiving placebo added to lenalidomide and rituximab) — representing a 57% reduction in the risk of disease progression, relapse or death.⁶

Minjuvi was generally well-tolerated, with a manageable safety profile.⁶ The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.⁶

In 2021, ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) to commercialise Minjuvi in Australia, New Zealand and Singapore.

"Follicular lymphoma is an incurable blood cancer and treatment options after relapse remain limited, with each recurrence more challenging to find effective treatments," said Carlo Montagner, ST Chief Executive Officer. "We are extremely proud to bring the first and only chemotherapy-free treatment option to eligible Australians with relapsed or refractory follicular lymphoma, addressing a critical need for new therapies that may lower the risk of disease progression, relapse or death."

"The Minjuvi approval represents the ninth time ST has successfully navigated the Project Orbis process since 2021," said Mr Montagner. "With TGA registration secured, we are committed to working with the Pharmaceutical Benefits Advisory Committee and Department of Health, Disability and Ageing to enable equitable access to Minjuvi for Australians with relapsed or refractory follicular lymphoma as soon as possible."

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: Minjuvi is not listed on the Pharmaceutical Benefits Scheme (PBS).

Important safety Information on Minjuvi⁷

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 (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

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. Tafasitamab 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). Incyte licenses exclusive worldwide rights to develop and commercialise tafasitamab from Xencor, Inc.

In Australia, Minjuvi is also indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Minjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

▼ This medicine is included in the TGA Black Triangle Scheme. Please report suspected adverse events to the TGA.

In the U.S., Monjuvi^® (tafasitamab-cxix) is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

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. Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb^® is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

About the inMIND Study^6,7

A global, double-blind, randomised, placebo-controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of 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).

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.⁶ Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001).⁶ The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results.⁶ Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56].⁶

Minjuvi was generally well-tolerated, with a manageable safety profile.⁶ Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab.⁶ The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.⁶

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:

Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG): MINJUVI tafasitamab. [Accessed 22 April 2026]. NCCN Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. Version 3.2026. Zinzani PL et al. Exp Hematol Oncol. 2024 Aug 22;13(1):87. Trotman J, et al. Intern Med J. 2019 Apr;49(4):422-433. Lymphoma Australia. Types of Lymphoma - Non-Hodgkin Lymphoma (NHL) - Indolent (slow-growing) B-cell NHL - Follicular Lymphoma. [Accessed 22 April 2026]. Sehn LH, et al. Lancet. 2026 Jan 10;407(10524):133-146. MINJUVI Australian Product Information; 2026 Apr 20.

View original content to download multimedia:https://www.prnewswire.com/news-releases/minjuvi-tafasitamab-for-relapsed-or-refractory-follicular-lymphoma-approved-in-australia-302751394.html

SOURCE Specialised Therapeutics

FAQ

What did Specialised Therapeutics announce about Minjuvi (INCY) on April 23, 2026?

They announced TGA registration of Minjuvi in combination with rituximab and lenalidomide for R/R follicular lymphoma in Australia. According to Specialised Therapeutics, approval follows Phase 3 inMIND data showing improved PFS and supports a chemotherapy-free dual-targeted option.

How much did Minjuvi improve progression-free survival in the inMIND Phase 3 trial?

Median PFS was 22.4 months with the Minjuvi regimen versus 13.9 months for control. According to Specialised Therapeutics, this represented a 57% reduction in risk of progression, relapse, or death in the trial population.

Is Minjuvi (INCY) covered by the PBS in Australia after TGA approval?

No, Minjuvi is not listed on the Pharmaceutical Benefits Scheme at this time. According to Specialised Therapeutics, they will engage with PBAC and the Department of Health to pursue equitable access and potential listing decisions.

What are the main safety concerns for Minjuvi in the approved combination?

Key safety issues include infections, neutropenia, and other myelosuppression requiring monitoring. According to Specialised Therapeutics, infections occurred frequently in inMIND and complete blood counts should be checked before each treatment cycle.

How many Australian patients participated in the inMIND trial supporting Minjuvi's approval?

Fifty-four Australians participated across 12 local trial sites. According to Specialised Therapeutics, the global inMIND study enrolled 652 patients, including 548 with relapsed or refractory follicular lymphoma.