Health Canada Approves VORANIGO for IDH-Mutant Glioma

Health Canada has recently approved VORANIGO (vorasidenib tablets) for the treatment of Grade 2 isocitrate dehydrogenase (IDH)-mutant glioma in both adults and children aged 12 and over, following surgical procedures. This approval marks a crucial medical advancement, introducing the first new therapy specifically for this condition in nearly a quarter of a century.

VORANIGO is a dual inhibitor targeting the mutant IDH1 and IDH2 enzymes and is specifically designed to cross the blood-brain barrier. This unique capability allows the medication to reduce the activity of these enzymes within the brain, contributing to disease management. The treatment is administered orally once a day, offering patients an accessible means of managing their glioma.

After being approved by the US Food and Drug Administration (FDA) in August 2024, Canada has now become the second country to authorize the use of VORANIGO. Gliomas are notably the second most prevalent type of cancer among Canadians under 40, and they typically spread within the brain, remaining incurable with the current range of therapies.

VORANIGO specifically targets the IDH mutation, which is present in approximately 60% to 70% of glioma cases. Lucie Rousseau, the general manager of Servier Canada, highlighted the significant impact of this approval. She noted that patients with Grade 2 IDH-mutant gliomas often face a bleak outlook with very limited treatment options outside of surgery. This diagnosis is particularly distressing for individuals in their 30s and 40s, who are often in the midst of building their careers and raising families.

Rousseau emphasized that VORANIGO brings a sense of hope and a new treatment possibility for these patients and their families. As Servier Canada continues to focus on developing targeted therapies, they stress the importance of identifying specific mutations and understanding their role in the progression of cancer. This approach ensures that patients receive treatments that are specifically tailored to their needs. Servier Canada is committed to leading the way in treating IDH-mutant glioma and remains dedicated to supporting the Canadian brain cancer community.

The approval of VORANIGO by Health Canada is based on findings from the Phase III INDIGO study. This study demonstrated a significant improvement in the time to next intervention and progression-free survival in patients with Grade 2 IDH-mutant glioma when compared to a placebo. These results underscore the potential of VORANIGO to effectively manage this challenging condition and improve the quality of life for patients battling this type of brain cancer.