Voranigo becomes 1st therapy in EU to target IDH-mutated glioma
Treatment blocks enzyme mutation driving tumor growth in glioma patients
The European Commission has approved Voranigo (vorasidenib) for certain types of glioma, marking the arrival of a new targeted pill poised to change the treatment strategy for a slow-growing but persistent form of brain cancer in the EU.
This approval, announced by the therapy’s developer, Servier, covers the first therapy specifically designed to shut down the activity of a mutated enzyme that fuels cancer growth in these tumors. The approval is for forms of glioma called predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma, in patients whose tumors carry one of two genetic mutations: isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172.
Voranigo is approved for use in patients 12 years and older, who weigh at least 40 kg (about 88 lbs), have had surgical intervention only, and are not in immediate need of radiation or chemotherapy. The approval is valid in all 27 member states of the European Union, as well as Norway, Liechtenstein, and Iceland.
“Today’s EU approval of Voranigo is a landmark moment for people in the EU living with IDH-mutated glioma who have been waiting more than two decades for new treatment options,” Islam Hassan, MD, global head of development-neuro-oncology and a senior director at Servier, said in a company press release.
Targeting the IDH mutation
IDH is an enzyme often mutated in people with some forms of glioma, particularly in younger adults. The mutated IDH enzyme disrupts cellular activity to drive cancer growth. IDH-associated gliomas frequently begin as slow-growing or low-grade tumors (Grade 1 and 2), but over time, they usually become more aggressive.
Voranigo is designed to slow cancer growth in patients with IDH-mutant tumors by inhibiting the activity of the mutated enzyme.
“Voranigo is the first EMA-approved therapy specifically designed to target mutant IDH enzymes in Grade 2 glioma and represents a long-awaited shift in the treatment paradigm,” Hassan said.
The commission’s decision comes a few months after a committee of the European Medicines Agency issued a positive opinion recommending approval. That recommendation was based mainly on data from the Phase 3 INDIGO clinical trial (NCT04164901), which tested Voranigo against a placebo in 331 people with IDH-mutant glioma. Results showed patients given Voranigo had significantly longer median progression-free survival. In other words, patients given the therapy were less likely to die or have their cancer worsen.
“We’re grateful to the researchers, patients and advocates who have helped expand our understanding of IDH inhibition and bring this breakthrough to the EU,” Hassan said.
The EU approval follows similar authorizations of Voranigo in the U.S., Canada, Brazil, Switzerland, Saudi Arabia, Japan, and other countries. Applications seeking approval of the therapy in additional markets are under review, according to Servier.
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