There is hope for glioma patients

Gliomas are tumors of the central nervous system (CNS) that develop from glial or precursor cells. According to the 2021 WHO classification, there are four main categories of gliomas, including diffuse gliomas that occur in adults. Diffuse gliomas are the most common primary malignant brain tumors in adults. For these tumors, pathogenesis and prognosis are closely linked to the presence (or absence) of mutations in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required to make a correct diagnosis. As of 2021, adult diffuse gliomas have been divided into three subcategories:

• Nemblastomas with IDH gene mutations (grades II-IV according to the WHO classification of CNS tumors);
• Sclerotomas with IDH gene mutations and codelation 1p/19q (grades II-III according to the WHO classification of CNS neoplasms);
• Glioblastomas multiforme with wild-type IDH genes (grade IV according to the WHO classification of CNS tumors).

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the registration of vorasidadeib for use in the European Union. A final decision by the European Commission on the matter is expected in the coming months.

Committee for Medicinal Products for Human Use (CHMP). The Committee for Medicinal Products for Human Use (CHMP) is recommending registration of the product for the monotherapy of essentially non-enlarged stage II nonsquamous staphyloma or stroma, with the R132 mutation of isocitrate dehydrogenase 1 (IDH1) or the R172 mutation of isocitrate dehydrogenase 2 (IDH2), in adults and adolescents over 12 years of age and weighing at least 40 kg, who have only undergone surgical intervention and who do not require immediate radiotherapy or chemotherapy.

If this product is registered, we will proudly be able to make the first molecularly targeted therapy for diffuse glioma with IDH gene mutations available to patients in Europe, undoubtedly representing a breakthrough in the treatment of this disease after nearly 25 years. For patients, it offers the chance for significant progress in the fight against this rare and incurable diffuse brain tumor. The aforementioned decision is a confirmation of Servier's unwavering commitment to supporting patients facing complex conditions by offering innovative therapeutic solutions," said Claude Bertrand, Vice President of Research and Development at Servier.

The CHMP's opinion is based on the positive results of the INDIGO trial, a global, randomized, placebo-controlled Phase III clinical trial that looked at the use of vorasidadeib in the treatment of patients with residual or recurrent stage II glioma with an IDH1 or IDH2 gene mutation whose prior treatment included surgery alone. The results of the study were presented at the plenary session of the 2023 American Society of Clinical Oncology (ASCO) annual congress, and were published simultaneously in the New England Journal of Medicine.

The therapy was registered in 2024 in the United States by the Food and Drug Administration (FDA), and has received marketing authorization in Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia and Switzerland. In addition, Servier has applied for marketing authorization in the United Kingdom, Japan and other countries, and these applications are currently being evaluated by the drug registration authorities in those countries.

Source: press mat.