Servier receives news that NICE draft guidance recommends vorasidenib (VORANIGO™q) for use in the NHS for eligible patients with low-grade glioma

Servier UK, entity of the Servier Group, an independent international pharmaceutical company governed by a foundation, announced yesterday that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending vorasidenib (VORANIGO™q) a once-daily oral targeted therapy indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma with a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, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.¹ 

Based on NICE’s final draft guidance published on March 31,  recommending vorasidenib from yesterday, immediate access is available to eligible patients across England and Wales via interim funding through the cancer drugs fund (CDF).

IDH mutant grade 2 gliomas frequently affect people with median age 20–40, and may cause a range of neurological symptoms, such as seizures.² With around 400 grade 2 glioma patients diagnosed each year in the UK,^3,4,5 these tumours are not curable and generally continue to grow if they are not treated. Until now, the standard of care has been surgery followed by active observation or, when needed, radiotherapy and chemotherapy.

Vorasidenib is the first and only approved therapy designed to target mutant IDH enzymes in grade 2 glioma and has the ability to cross the blood-brain barrier.⁶ The blood-brain barrier normally prevents most drugs from reaching the brain.  At diagnosis, patients are tested for the presence of an IDH1 or IDH2 mutation and the identification of this mutation means that they are potentially eligible for treatment with vorasidenib.

Paula Valencia, General Manager, Servier UK (pictured), said: “We are so pleased that based on the NICE draft guidance, eligible people living with Grade 2 IDH-mutant glioma in England and Wales will from today be able to access vorasidenib through the NHS via interim funding through the CDF. This marks a significant milestone for patients, their families and their healthcare teams who have been waiting for new options to help slow disease progression for over 20 years.

“Our focus has always been on ensuring that innovation translates into real-world access, so now we turn our attention to ensure this medicine is available to all eligible patients across the UK.”

The draft guidance is based on results from the pivotal INDIGO study, an international, double-blind, randomised, placebo-controlled, phase 3 trial, which assessed the efficacy and safety of vorasidenib therapy in patients with residual or recurrent grade 2 IDH-mutant glioma who had been treated with surgery only. The study demonstrated that vorasidenib increased the time to tumour progression (a median of 27.7 months [17.0-NE] for vorasidenib vs 11.1 months [11.0-13.7] for placebo) (HR, 0.39; 95 per cent CI, 0.27 to 0.56; 1-sided p<0.001). The most common adverse reactions were increased ALT (59.3 per cent), increased AST (45.5 per cent), increased GGT (37.7 pr cent), fatigue (36.5 per cent) and diarrhoea (24.6 per cent)¹. The most common Grade ≥3 adverse events for patients receiving vorasidenib vs placebo were an increase in liver enzymes (ALT (9.6% vs 0) and AST (4.8 per cent vs 0).^1,6

In a statement, Mary Burton and Dawn Emerton, Trustees, of the Astro Brain Tumour Fund, said: ‘The draft guidance to recommend vorasidenib for use in the NHS is a hugely important moment for the brain tumour community.

“This decision will enable access to the first new therapy in over two decades, offering hope of delaying disease progression for eligible Grade 2 glioma patients and their families. This is a powerful reminder of what can be achieved when patients, clinicians, and industry work together to drive change. We hope this marks the beginning of a new era of progress for everyone affected by brain tumours.”

In addition to this draft recommendation by NICE which makes the treatment available from yesterday for eligible patients in England and Wales via interim funding through the CDF, vorasidenib has also been accepted for use in Scotland by the Scottish Medicines Consortium (SMC). This means that vorasidenib is now accepted for use in the NHS Scotland 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, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.

References

1. VORANIGO® SmPC.
2. Pan Z. et al. Front Oncol. 2025; 15: 1628195.
3. NICE TA23 Overview | Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer) | Guidance | NICE last accessed March 2026
4. Weidl D. et al. J Neurooncol. 2025; 174: 391–400
5. Bauchet L. et al. Neurochirurgie. 2025; 71 (3): 101627
6. Mellinghoff IK. et al. N Engl J Med. 2023; 389: 589-601