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Vebreltinib's Third Indication for NSCLC with MET Amplification was Officially Accepted by China CDE and Granted as Priority Review
On December 25, 2024, Avistone announced that its wholly-owned subsidiary, Beijing Pearl Biotechnology Co., Ltd., submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for a new indication of Vebreltinib (PLB-1001). This application has been officially accepted by CDE and granted as priority review. The proposed indication is for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification. This milestone indicates that the field of NSCLC with MET Amplification is expected to enter a new era of precision-targeted therapy.