Servier Canada has announced Health Canada's approval of VORANIGO (vorasidenib tablets) for Grade 2 isocitrate dehydrogenase (IDH)-mutant glioma treatment in adults and paediatric patients aged 12 years and above, following surgery.

The approval represents the first therapy and a major advancement in treating the disease in almost 25 years.

VORANIGO, a dual inhibitor of mutant IDH1 and IDH2 enzymes, is designed to penetrate the blood-brain barrier.

The treatment reduces the activity of these enzymes, helping to control the disease. The once-daily oral dosage offers patients the chance to manage their condition actively.

Following its approval by the US Food and Drug Administration (FDA) in August 2024, Canada has become the second country to authorise VORANIGO.

Gliomas, the second-most common cancer type in Canadians under 40 years of age, spread within the brain and are not curable with current therapies.

VORANIGO addresses the IDH mutation found in 60% to 70% of glioma patients.

Servier Canada general manager Lucie Rousseau stated: “Patients living with Grade 2 IDH-mutant gliomas must contend with a grim prognosis that has few options outside of surgery.  This is a devastating diagnosis, particularly for individuals in their 30s and 40s who are often raising families and at the peak of their careers.

“Voranigo offers these patients and their families hope. As we continue to develop targeted therapies, identifying specific mutations and understanding their role in cancer progression is critical to ensuring that patients receive the right treatment at the right time. We are proud to be leading the way in IDH-mutant glioma therapy and remain dedicated to supporting the Canadian brain cancer community.” 

Health Canada's approval of VORANIGO is based on the Phase III INDIGO study results, which showed improvement in time to next intervention and progression-free survival in subjects with Grade 2 IDH-mutant glioma against placebo.