Clinical Evaluation of Anaplastic Lymphoma Kinase (ALK) Inhibitors for the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer Based on the 2nd Edition of China’s Drug Evaluation and Selection Guideline

Zhijun Guo,1,2,* Yunhui Zhang,1,* Haoyun Chen,1 Xinyi Dong,3 Weicheng Lei,1 Luhua Zhong,1 Jiali Yang,1 Huanjun Huang,1 Zhuojia Chen,1 Weiting Liang11Department of Pharmacy, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, People’s Republic of China; 2Department of Pharmacy, Heyou Hospital, Foshan, Guangdong, 528311, People’s Republic of China; 3School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, Guangdong, 510006, People’s Republic of China*These authors contributed equally to this workCorrespondence: Zhuojia Chen; Weiting Liang, Department of Pharmacy, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, People’s Republic of China, Tel +86 20-87343390, Fax +86 20-87343323, Email [email protected]; [email protected]: To provide a reference for healthcare organizations in the selection and rational use of ALK inhibitors, based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition).Methods: According to the 2nd edition of China’s drug evaluation and selection guideline released in 2023, relevant databases such as PubMed, Micromedex, and Medlive, drug labels, and clinical guidelines were searched for specific drug information. We systematically evaluated eight ALK inhibitors marketed in China for pharmacological properties, efficacy, safety, economy, and other attributes using a percentage scoring method.Results: The ranking of ALK inhibitors was derived from a structured scoring framework based on the 2nd Edition of China’s Drug Evaluation and Selection Guideline. The final assessment result scores from highest to lowest were alectinib (78.70 points), lorlatinib (78.70 points), brigatinib (78.50 points), ensartinib (73.30 points), iruplinalkib (72.55 points), ceritinib (71.50 points), envonalkib (71.15 points), crizotinib (70.60 points).Conclusion: Based on the second edition of China’s drug evaluation and selection guideline and combined with the clinical application characteristics of ALK inhibitors, this study performed a multidimensional scoring of eight ALK inhibitors. The evaluation results could provide a reference for medical institutions in the introduction and elimination of ALK inhibitors.Keywords: anaplastic lymphoma kinase, tyrosine kinase inhibitors, non-small cell lung cancer, drug evaluation, clinical application