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Vorasidenib Approved in China's Boao Lecheng Pilot Zone for IDH-Mutant Glioma

8 months ago2 min read

Key Insights

  • Vorasidenib, a dual inhibitor of IDH1 and IDH2, has been approved for clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China.

  • This approval allows Chinese patients with IDH-mutant diffuse glioma access to the drug before its official registration in China, aligning with global availability.

  • A real-world study is underway in Boao Lecheng to evaluate vorasidenib's safety and efficacy in Chinese patients, potentially accelerating research by 1-2 years.

West China Lecheng Hospital has initiated outpatient treatment with vorasidenib for Chinese patients with IDH-mutant diffuse glioma, following its approval for clinical use in the Boao Lecheng International Medical Tourism Pilot Zone. This makes vorasidenib available to patients in China ahead of its official national approval. Vorasidenib represents a first-in-class targeted therapy addressing IDH mutations, which are crucial in the development of gliomas.
The approval marks the first use of vorasidenib in Asia and precedes its availability in Europe. Vorasidenib has already secured approvals in the United States (August 6, 2024), Canada, Australia, Israel, Switzerland, and the UAE. The National Medical Products Administration has also granted approval for a clinical trial III, paving the way for official registration in China.
Gliomas, the most prevalent primary malignant brain tumors, pose significant therapeutic challenges. Despite multimodal treatments including surgery, chemoradiation, and chemotherapy, over 90% of patients experience recurrence. The identification of IDH mutations as key oncogenes has spurred the development of targeted therapies like vorasidenib, a dual inhibitor of IDH1 and IDH2.
"Servier, as an independent group governed by a non-profit foundation, has always prioritized addressing patients' medical needs," stated Manuel RUIZ, General Manager of Servier China. "This commitment drives our investment in research and the development of innovative therapies. The success of Voranigo's launch in Bo'ao is rooted in the belief that every patient should have access to the best treatments available, and we are committed to making that a reality here in China."
A real-world study is being conducted in Boao Lecheng to assess the safety and efficacy of vorasidenib specifically in Chinese patients. This approach can expedite research, potentially delivering results 1-2 years faster than traditional clinical trials.
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