Zhonghua zhong liu za zhi [Chinese journal of oncology] · 2026
[Expert consensus on iruplinalkib for the treatment of ALK-positive non-small cell lung cancer (2026 edition)].
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Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care, Chinese Association for Clinical Oncologists
Аннотация
Anaplastic lymphoma kinase (ALK) fusion gene is one of the most common driver genes in non-small cell lung cancer (NSCLC). ALK-tyrosine kinase inhibitors (TKIs) have become the standard treatment option for patients with advanced ALK gene fusion positive NSCLC. Currently, the China National Medical Products Administration (NMPA) has approved ten ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, envonalkib, dirozalkib and conteltinib. Iruplinalkib is a novel ALK-TKI independently developed in China. On June 27, 2023, the NMPA approved iruplinalkib for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on or were intolerant to crizotinib. On January 16, 2024, the NMPA approved iruplinalkib for first-line treatment of patients with locally advanced or metastatic ALK-positive NSCLC patients. To help clinicians better understand the efficacy and safety of iruplinalkib and to facilitate its more rational clinical application, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists organized experts to develop the "Expert consensus on iruplinalkib for the treatment of ALK-positive non-small cell lung cancer (2026 edition)". This consensus provides systematic and comprehensive update of clinical research data on iruplinalkib published before June 25, 2026, based on the 2024 edition. It covers common clinical issues and provides corresponding recommendations for the use of iruplinalkib in the treatment of ALK-positive NSCLC.