Chinese biotech Avistone Pharmaceuticals has won full approval in China for vebreltinib (also known as bozitinib) for a rare subtype of glioblastoma, making the molecule the world’s first c-Met inhibitor to be green-lighted for this form of central nervous system tumor with c-Met alterations.
Key Takeaways
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Avistone's vebreltinib has become the first c-Met inhibitor worldwide to be approved for a rare subtype of glioblastoma, in China.
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The full approval was based on positive overall survival results from the 84-patient Phase II/III FUGEN trial, which compared vebreltinib with chemotherapy in previously-treated glioblastoma with the PTPRZ1-MET fusion
The approval was based on positive overall survival findings from the 84-patient Phase II/III FUGEN clinical study that compared vebreltinib with chemotherapy comprising the dose-dense regimen of temozolomide or a combination of etoposide and cisplatin in certain Chinese glioblastoma
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