Servier’s Vorasidenib Receives Approval as Clinical Urgently Needed Drug to be Used in Boao Lecheng Pilot Zone

HAINAN, China, Nov. 24, 2024 /PRNewswire/ — It was announced that West China Lecheng Hospital has successfully introduced Vorasidenib for treatment at clinical practices, and the treatment began at outpatient from today on. This announcement was made at the press conference themed “Vorasidenib Launch with West China Lecheng Hospital and Kick Off the Preparation to Real-World Study”. It implies that Vorasidenib, the first-in-class targeted therapy of dual inhibitor IDH could benefit Chinese patients with IDH-mutant diffuse glioma, in line with global launches. Meanwhile, it marks that Vorasidenib, before getting approval of national New Drug Application, was approved as a clinical urgently needed imported drug to be used in Boao Lecheng International Medical Tourism Pilot Zone. This is also the first use in Asia and prescribed before Europe to serve patients.

Vorasidenib is the first-in-class innovative targeted therapy for IDH-mutant diffuse glioma over the last 20 years. After its approval in the US on August 6, 2024, Vorasidenib has been approved respectively in Canada, Australia, Israel, Switzerland and UAE. Vorasidenib has obtained the approval for clinical trial III from National Medical Products Administration and is in the preparation for official registration in China.

Gliomas represent the most common primary malignant brain tumors and the most common tumors of the central nervous system. Currently, treatment options for glioma are very limited. Even with a multi-modal approach combining surgical resection, concurrent chemoradiation and adjuvant chemotherapy, over 90% of glioma patients experience recurrence and disease progression.^[1]

IDH mutation has been identified as an important oncogene for glioma and plays a pivotal role in its occurrence and development. As the world’s first dual inhibitor of IDH1 and IDH2, Vorasidenib can offer significant benefits to patients compared with current treatments, particularly for those with IDH1 and IDH2 mutations.

Manuel RUIZ, General Manager of Servier China, stated, “Servier, as an independent group governed by a non-profit foundation, has always prioritized addressing patients’ medical needs and we are committed to work together with healthcare professionals to improve patients’ treatment outcomes and quality of life. 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.”

Meanwhile, a real-world study is underway simultaneously in Boao Lecheng to assess the safety and efficacy of Vorasidenib in the Chinese patients. It can accelerate the research process, often delivering results 1-2 years faster than traditional clinical trials.

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