Friday, April 26, 2024
Beijing Avistone Biotechnology Co., Ltd. (commonly known as Avistone Biotechnology or Avistone) has gained approval from the Chinese National Medical Products Administration (NMPA) to extend the application of vebreltinib for treating adult patients with isocitrate dehydrogenase (IDH) mutant Astrocytoma (World Health Organization grade 4) carrying the PTPRZ1-MET fusion gene, or glioblastoma patients with a history of low-grade disease and the PTPRZ1-MET fusion (ZM fusion) gene, who have previously failed other treatments. This supplementary New Drug Application (sNDA) approval establishes vebreltinib as the first c-Met inhibitor worldwide approved for treating Central Nervous System (CNS) tumors with c-Met alteration.
In November 2023, vebreltinib had received conditional approval from the NMPA for treating metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC).
Glioma represents a challenging primary malignant intracranial tumor, constituting around 46% of intracranial tumors. The current standard treatment strategies involve surgery, radiotherapy, and chemotherapy, but the prognosis remains poor, with a 5-year overall survival (OS) rate of less than 10% for malignant glioma patients.
Previous studies in Chinese patients have indicated that approximately 12% of brain gliomas exhibit MET fusion. Among them, the PTPRZ1-MET fusion gene (referred to as ZM fusion) is found in about 14% of glioblastomas with a history of lower-grade disease. This fusion often co-occurs with MET Exon 14 skipping mutations and is associated with a dismal prognosis.
The approval of vebreltinib for ZM fusion-positive glioma indications is based on the favorable outcomes of the FUGEN study (NCT06105619). This study, involving 84 patients, was a randomized controlled, open-label, multicenter clinical registration phase II/III study. It compared the efficacy and safety of vebreltinib with dose-dense temozolomide or the combination of etoposide and cisplatin, with OS as the primary endpoint.
Results showed that the median OS for patients on vebreltinib monotherapy regimen was 6.31 months, compared to 3.38 months for the control group, reducing the risk of death by 48% and significantly enhancing the survival of patients with recurrent ZM fusion glioma. Importantly, vebreltinib demonstrated an acceptable safety profile.
Avistone, remarked, "Developing drugs for MET targets has always been challenging. This approval not only signifies a triumph in translational medicine but also heralds the dawn of targeted therapy in the realm of brain glioma."
Source: businesswire.com
