甲磺酸奥希替尼片(泰瑞沙)

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沃瑞沙和泰瑞沙联合疗法中国获批,二线治疗晚期非鳞非小细胞肺癌
Xin Jing Bao· 2025-07-01 04:57
Core Insights - AstraZeneca announced the approval of the combination therapy of Savolitinib (brand name: Worishe) and Osimertinib (brand name: Taris) by the National Medical Products Administration of China for treating locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients with EGFR gene mutations and MET amplification after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1 - Savolitinib is the first selective MET inhibitor approved in China, developed in collaboration with Hutchison China MediTech, and is indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 alterations [1] - Osimertinib is an irreversible third-generation EGFR-TKI with confirmed clinical activity in treating NSCLC patients, including those with central nervous system metastases [1][2] Group 2 - The approval is based on the SACHI Phase III clinical trial data, which achieved the predefined primary endpoint of progression-free survival (PFS) in a pre-specified interim analysis [2] - The combination therapy was included in the breakthrough therapy designation by the National Medical Products Administration in 2024 and received priority review for its new drug application in 2025 [2] - The approval marks the third indication for Savolitinib in China, highlighting its significance in addressing complex challenges in lung cancer treatment [2]