First new treatment in more than 20 years for rare, incurable brain cancer, listed on the PBS
Servier Australia
Key Facts:-
VORANIGO® (vorasidenib) is available on the Pharmaceutical Benefits Scheme (PBS) for eligible patients living with Grade 2 IDH-mutant gliomai
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This is the first new treatment option in more than 20 years to be approved and listed on the PBS for eligible Australians living with this rare, incurable brain cancer. 1
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IDH-mutant glioma is the most common malignant primary brain tumour in adults under 50 years of age.ii
ADELAIDE, AUSTRALIA – 2 August 2026
Servier Australia welcomes today’s Government announcement that Australians living with Grade 2 IDH-mutant astrocytoma or oligodendroglioma - a rare, incurable brain cancer – will have access to the first new treatment in more than 20 years. From 1 August VORANIGO® (vorasidenib) will be listed on the Pharmaceutical Benefits Scheme (PBS) for adults and adolescents aged 12 years and older with a susceptible IDH1 or IDH2 mutation who have not previously received systemic anticancer therapy or radiotherapy and meet the PBS eligibility criteria.1,iii
IDH-mutant glioma is the most common malignant primary brain tumour in adults under 50, affecting an estimated 3,230 Australians.2 Typically diagnosed between the ages of 20 and 45, the slow-growing but incurable disease can progress over many years, leaving people to face ongoing uncertainty, seizures, cognitive changes, physical disability and loss of independence while building careers, raising families and planning their futures.iv,v,vi
Until now, treatment options have largely relied on surgery, active monitoring and, where needed, radiotherapy or chemotherapy to slow disease progression.vii VORANIGO® (vorasidenib) is the first targeted treatment approved in Australia for Grade 2 IDH-mutant glioma. It is used to treat specific brain cancers with changes (mutations) in the IDH1 or IDH2 genes. These mutations cause abnormal proteins to form, leading to changes within cells that contribute to the growth of the cancer. VORANIGO® works by blocking the mutated proteins, helping to slow or stop the cancer from growing.3
Associate Professor Jim Whittle, Medical Oncologist at Peter MacCallum Cancer Centre and Co-Director of Research Strategy, The Brain Cancer Centre at WEHI states "For people living with IDH-mutant glioma, managing the disease involves making complex treatment decisions over many years. Caring for these patients often involves balancing long-term disease control with preserving neurological function and quality of life. Access to vorasidenib through the PBS provides clinicians with a targeted treatment option, adding another tool to the toolbox and supporting greater choice when discussing treatment options with patients”.
The PBS listing has also been welcomed by the Australian Brain Tumour Collaborative (ABTC), which has worked alongside patients, clinicians, researchers and industry to improve awareness and outcomes for people living with IDH-mutant glioma.
“Behind every IDH-mutant glioma diagnosis is a person, a family and a future forever changed. For our community, today's PBS listing is a significant milestone after years of advocacy to improve access to new treatment options for Australians living with this rare brain cancer.” said Craig Cardinal, Australian Brain Tumour Collaborative spokesperson
“Access to treatment is only one part of the journey. People living with brain cancer and their families also need coordinated multidisciplinary care, psychosocial support and practical services throughout every stage of their diagnosis." He added.
Mélanie Chamaux, General Manager, Servier Australia and New Zealand, said "We are incredibly proud of the PBS listing of VORANIGO®, which marks an important milestone for Australians living with IDH-mutant glioma. It reflects years of shared commitment from patients, families, clinicians, researchers, advocacy organisations and the Department of Health, Disability and Ageing, all united by a common goal: changing the trajectory of care for people living with IDH-mutant glioma. The listing represents a collective achievement of the healthcare system recognising therapeutic progress and the meaningful difference innovative medicines can make for patients, their families and the broader community.
We hope this milestone brings renewed confidence and optimism to those facing the challenges of this disease.”
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About VORANIGO® (vorasidenib)
VORANIGO® (vorasidenib) is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and paediatric patients 12 years and older with residual or recurrent disease, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention and have not previously received systemic anticancer therapy or radiotherapy. Patients should speak with their treating specialist to determine whether VORANIGO is appropriate for them. For more information, refer to the Consumer Medicine Information for VORANIGO.
Safety: The most important potential adverse reaction is increased liver enzymes, which requires regular liver function monitoring before and during treatment. Other common side effects include fatigue, headache, diarrhoea, nausea, and muscle aches or stiffness. Precautions: Liver function should be monitored before and throughout treatment. Patients should not use VORANIGO during pregnancy and should discuss barrier contraception requirements with their healthcare professional, as hormonal contraceptives may be less effective while taking VORANIGO. Contraindications: VORANIGO should not be used in patients with hypersensitivity to vorasidenib or any of its ingredients. It should not be used during pregnancy or breastfeeding. Interactions: VORANIGO may interact with certain medicines, including some antibiotics, hormonal contraceptives, anaesthesia, immunosupressants, and medicines used to treat epilepsy, depression, and severe pain. Patients should tell their healthcare professional about all medicines, vitamins or supplements they are taking before starting treatment.
For further information, please refer to the Consumer Medicine Information: VORANIGO
Notes to Editors
About IDH-mutant glioma
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IDH-mutant glioma is the most common malignant primary brain tumour diagnosed in adults under 50 and can affect people during their most productive years.
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The disease is chronic and incurable and can slowly erode health and independence over many years.
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IDH-mutant glioma is particularly characterised by a high burden of seizures, which are unpredictable and cause significant physical and psychological distress.
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Australians living with IDH-mutant glioma can face major challenges including inability to work, inability to drive, loss of independence and anxiety associated with the need to ‘watch and wait’ to see what the tumour will do.
About Servier
Independent pharmaceutical company Servier is fast becoming a global leader in oncology, governed by a foundation, Servier approaches innovation with a long-term vision, free of influence from shareholders. Servier devotes close to 70% of its research and development budget to Oncology and is driven by the belief that everyone deserves a chance to fight their illness, regardless of how common or rare it is.
About the Australian Brain Tumour Collaborative (ABTC)
The Australian Brain Tumour Collaborative (ABTC) is a national alliance of leading brain tumour organisations, clinicians, researchers and advocates working together to improve outcomes for Australians affected by brain tumours. Established in 2022, the ABTC provides a united, evidence-based voice to government and the broader community, advocating for improved research, equitable access to multidisciplinary care, clinical trials, and comprehensive support for patients, families and carers. Through collaboration and lived experience, the ABTC is committed to driving meaningful policy change and improving the quality of life for everyone impacted by brain tumours. For more information, visit www.australianbraintumourcollaborative.org.
Disclosure
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Contact details:
BONNIE LEIBEL
Senior Director- Cube
+61 437 819 965 | [email protected]