Servier Canada has secured approval for VORANIGO (vorasidenib tablets), the first targeted therapy for the treatment of Grade 2 isocitrate dehydrogenase (IDH)-mutant glioma in adults and pediatric patients aged 12 years and older, following surgery. VORANIGO offers glioma patients the convenience of a once-daily oral treatment, providing them with an opportunity to actively manage their disease. Canada is the second country after the United States to receive regulatory authorization for VORANIGO.
Gliomas are the second-most common type of cancer in Canadians under 40 years old and the second-most common cause of cancer-related deaths in this group. These slow-growing brain tumors spread within the brain leading to disruptions in neurological function, seizures, and cognitive impairment. Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumours diagnosed in adults younger than 50 years of age. They are not curable with current therapies and without treatment they continue to grow and infiltrate normal brain tissue. The annual incidence of gliomas is approximately of six cases per 100,000 individuals worldwide.
A key concern with low-grade gliomas is their progression to high-grade gliomas, which are harder to treat and carry a poor prognosis. Research shows that 60-70% of patients with gliomas have the targetable IDH mutation that VORANIGO addresses.
“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,” said Lucie Rousseau, General Manager of Servier Canada.
“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.”
In healthy human cells, a family of enzymes called isocitrate dehydrogenases (IDH) help break down nutrients and generate energy for cells. Mutations in IDH1 and IDH2 genes are associated with a variety of cancers, where they prevent cells from differentiating or specializing into the kind of cells they are ultimately supposed to become. When cells cannot differentiate properly, they may begin to grow out of control. In IDH-mutant gliomas, VORANIGO works by reducing the activity of the mutant IDH1 and IDH2 enzymes, to help control the disease.
Vorasidenib, a dual inhibitor of the mutant IDH1 and IDH2 enzymes, was developed for penetration across the blood–brain barrier.
“This therapy represents a significant advancement in the treatment of Grade 2 IDH-mutant glioma,” says Dr. Mary Jane Lim-Fat, neuro-oncologist at Sunnybrook Health Sciences Centre. “Slowing tumour progression and delaying the emergence of high-grade disease are key goals in glioma treatment, and this therapy helps to address those challenges.”
