#None #Servier #Glioma #VORANIGO

Servier's VORANIGO® Receives Positive CHMP Opinion

On July 25, 2025, Servier Pharmaceuticals announced a significant milestone in cancer treatment with the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This development pertains to VORANIGO® (vorasidenib), a promising treatment option aimed at adults and adolescents suffering from Grade 2 IDH-mutant diffuse glioma.

Background on VORANIGO®

VORANIGO is the first and only targeted therapy available for treating Grade 2 gliomas characterized by mutations in isocitrate dehydrogenase (IDH1 or IDH2). This revolutionary medication is positioned for adult and adolescent patients aged 12 years and older, who weigh at least 40 kg, and have undergone surgical options rather than immediate chemotherapy or radiation treatments.

The application for the marketing authorization of VORANIGO will now be evaluated by the European Commission (EC), which holds the authority to grant approvals across the EU’s 27 member states, along with Norway, Liechtenstein, and Iceland.

Trial Success Leading to Approval

The positive CHMP opinion is grounded in the encouraging results from the pivotal Phase 3 INDIGO trial—a global, randomized, double-blind placebo-controlled study evaluating VORANIGO in patients whose Grade 2 gliomas had returned or persisted post-surgery. This trial famously presented its findings at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and was also featured in The New England Journal of Medicine.

Servier’s Vice President of Clinical Development, Dr. Susan Pandya, expressed optimism regarding the approval process. She stated this recommendation brings the company closer to providing effective treatment options for patients afflicted by a type of glioma that has historically lacked available therapies. Dr. Pandya showcased commitment to further dialogue with regulatory bodies worldwide to transition VORANIGO into a recognized standard of care.

Global Reach and Future Aspirations

VORANIGO has already made waves beyond Europe, having received approval from the U.S. Food and Drug Administration (FDA) in August 2024 following designations for Fast Track, Breakthrough, and Orphan Drug status. It is already available in markets such as Canada, Australia, and various regions in the Middle East and Europe. Servier is also in the process of submitting marketing authorization applications in the UK, Japan, and several other countries.

Despite its triumphant global pathway, VORANIGO remains investigational within the EU, pending the formal approval process.

Servier's Commitment to Oncology

As a leading figure in oncology, Servier operates under a non-profit foundation and dedicates a substantial portion of its research and development funds towards oncology advancements. The company's vision revolves around identifying mutations and developing targeted therapies that improve patient treatment experiences.

With a focus on innovation, Servier aims to foster collaborations and partnerships that enhance the development of new cancer therapies. Their approach ensures that patients receive the right treatments at the most opportune moments in their healthcare journey.

Implications for Patients

The approval of VORANIGO could vastly change the treatment landscape for patients with Grade 2 IDH-mutant glioma in Europe. Patients suffering from malignant brain tumors often experience a myriad of challenges due to limited therapy options. If VORANIGO gains full regulatory approval, it could herald a new era for glioma management across the region, firmly placing Servier in a position as a crucial player in cancer care.

For further insights on VORANIGO and ongoing updates regarding its approval journey, one can explore the official Servier website or reach out directly to their media relations.

In summary, the recent positive recommendation for VORANIGO marks a pivotal moment for Servier and its commitment to delivering vital cancer treatments to patients who need them the most.