Servier’s Voranigo® Wins Global Praise, Heralding New Era for Glioma Care

SURESNES, France – December 08, 2025

In a resounding endorsement of a major therapeutic advancement, Servier's precision oncology drug Voranigo® (vorasidenib) has been decorated with a trio of prestigious international honors. The pharmaceutical group announced that its first-in-class treatment for a specific type of low-grade brain cancer has secured the 2025 Prix Galien Awards in the United States, Poland, and the inaugural Bridges edition, all for 'Best Product for Orphan/Rare Diseases.' This sweep of accolades, considered the pharmaceutical industry’s equivalent of the Nobel Prize, signals a pivotal moment for patients with IDH-mutant glioma and validates a new standard of care that has been decades in the making.

For patients and clinicians, these awards are more than just industry recognition; they represent global validation of a drug that fundamentally alters the treatment trajectory for a disease that often strikes people in the prime of their lives.

The Weight of a Global Endorsement

The Prix Galien is not an award given lightly. Its judging committees are composed of preeminent scientific and medical leaders, including Nobel laureates, who evaluate innovations based on their potential to improve the human condition. Winning in a single country is a significant achievement; winning across multiple geographies in the same year is an exceptional testament to a product's impact.

By securing the Prix Galien USA and Poland, Voranigo® demonstrated its breakthrough status in established and influential markets. The addition of the inaugural Prix Galien Bridges Award is particularly noteworthy. This new honor recognizes innovation across Nordic countries and their growing biopharmaceutical ties with key European and Middle Eastern nations, highlighting Voranigo®'s widespread relevance and the international consensus on its importance.

"We are truly honored to receive these prestigious distinctions in several countries. It recognizes the scientific progress that Voranigo® can bring to patients living with glioma across the world," said Arnaud Lallouette, Executive Vice-President, Global Medical & Patient Affairs at Servier. The awards cement the drug's position not just as a scientific success, but as a critical tool in the fight against a rare and debilitating cancer.

A Paradigm Shift for IDH-Mutant Glioma

To understand the significance of Voranigo®, one must understand the challenge of treating grade 2 IDH-mutant astrocytoma and oligodendroglioma. These are slow-growing but relentless brain tumors that are most often diagnosed in patients in their 30s and 40s. For years, the standard of care after initial surgery was a difficult choice: a period of “watchful waiting” where the tumor inevitably progresses, or immediate, aggressive treatment with radiation and chemotherapy, both of which carry substantial risks of long-term, irreversible neurocognitive damage.

The pivotal Phase 3 INDIGO clinical trial changed this paradigm. The results, published in The New England Journal of Medicine, were so compelling that the trial was unblinded early. Patients taking vorasidenib saw their median progression-free survival extended to 27.7 months, a dramatic improvement over the 11.1 months observed in the placebo group. This translated to a 61% reduction in the risk of disease progression or death.

More importantly for patients’ quality of life, the drug significantly delayed the time to the next medical intervention. One leading neuro-oncologist involved in the research called it a "huge benefit," noting that the "strikingly positive data" represented a historic moment. Another specialist expressed their excitement upon seeing the results, stating they were "watching history being made" for a patient community that had seen little progress for decades. The ability to postpone radiation and chemotherapy, potentially for years, offers patients a chance to preserve their cognitive function, careers, and family life.

From Waiting Game to Targeted Attack

Voranigo® is the first-ever targeted therapy approved for this specific type of glioma. It works as a brain-penetrant dual inhibitor, meaning it can cross the blood-brain barrier to directly target the mutant IDH1 and IDH2 enzymes that drive the tumor's growth. This precision approach is a world away from the blunt instruments of traditional chemotherapy and radiation.

The INDIGO trial data showed that vorasidenib not only slowed tumor growth but, in some cases, even caused tumors to shrink, all while demonstrating a manageable safety profile. Patients on the drug maintained their health-related quality of life and even showed improved seizure control compared to placebo. For a young adult facing a lifelong battle with brain cancer, this represents a profound shift from passive waiting to proactive, targeted management of their disease with a well-tolerated oral medication.

Patient advocacy groups have championed the need for such an advancement. While celebrating the clinical breakthrough, they also highlight the next crucial step: ensuring broad and equitable access. The journey from regulatory approval to routine availability on national health systems, like the NHS in the UK, can be fraught with challenges, and patient voices are critical in demonstrating the urgent, unmet need for therapies that prioritize long-term quality of life.

A Vindicated Strategy of Precision and Focus

The success of Voranigo® is no accident; it is the direct result of a focused, long-term strategy by Servier to become a leader in oncology, particularly in hard-to-treat and rare cancers. A cornerstone of this strategy was the company's bold acquisition of Agios Pharmaceuticals' oncology business in 2021 for up to $2 billion. This move brought vorasidenib, then a promising Phase 3 asset, into the Servier pipeline and significantly expanded its scientific and commercial footprint in the United States.

Governed by a foundation, Servier has dedicated over half of its R&D budget to oncology, concentrating on immuno-oncology and targeted therapies. The company's pipeline of 34 oncology projects reflects a deep commitment to translating cutting-edge science into meaningful patient outcomes. The global recognition for Voranigo® serves as powerful validation of this patient-centric approach, proving that strategic investment in areas of high unmet medical need can yield transformative results.

As Voranigo® becomes available to patients in dozens of countries from the United States and Europe to Japan and Brazil, its journey from a laboratory concept to an award-winning therapy offers a new horizon of hope. It marks a pivotal victory in the field of neuro-oncology, providing patients not just with another treatment, but with the invaluable gift of time.