{"entity":{"id":"ensartinib","kind":"drug","name":"Ensartinib","aka":[],"tldr":"A Chinese-developed ALK pill approved in the US in December 2024 for first-line ALK-positive lung cancer.","summary":"Ensartinib is a potent second-generation ALK tyrosine kinase inhibitor with activity against crizotinib-resistant mutations and penetration into the central nervous system. In the eXalt3 trial (JAMA Oncology 2021) it beat crizotinib in ALK-TKI-naive NSCLC, with median progression-free survival of 25.8 versus 12.7 months. It was approved in China in 2020 for use after crizotinib and in 2022 for first-line treatment, and the FDA approved it in December 2024 for ALK-inhibitor-naive locally advanced or metastatic disease, developed in the US by Xcovery. Rash is its characteristic toxicity, in contrast to the pulmonary events of brigatinib or the metabolic effects of lorlatinib. It has not been compared directly with alectinib or lorlatinib, so its place among first-line ALK drugs is still being worked out. Ensartinib adds a further option to an already crowded class.","status":"approved","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Ensartinib","links":[{"label":"eXalt3 (JAMA Oncol 2021)","url":"https://doi.org/10.1001/jamaoncol.2021.3523"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=ensartinib"},{"label":"FDA novel approvals 2024","url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024"}],"tags":["gap-fill"],"related":["alk-fusion"],"cancers":["nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk"],"drugs":[],"companies":["xcovery","betta"],"institutions":[],"pathways":[],"terms":[],"trials":["nct02767804","nct07448116"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Ensacove","modality":"Small-molecule ALK TKI (second generation)","mechanism":"Potent ALK inhibitor with activity against crizotinib-resistant mutations and CNS penetration.","approvals":[{"region":"CN","year":2020,"indication":"ALK-positive NSCLC after crizotinib"},{"region":"US","year":2024,"indication":"ALK-positive locally advanced or metastatic NSCLC, ALK-inhibitor-naive"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ensartinib/","neighbours":{"biomarker":[{"id":"alk-fusion","kind":"biomarker","name":"ALK fusion (ALK-positive)","route":"/biomarkers/alk-fusion/"}],"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"company":[{"id":"betta","kind":"company","name":"Betta Pharmaceuticals","route":"/companies/betta/"},{"id":"xcovery","kind":"company","name":"Xcovery","route":"/companies/xcovery/"}],"trial":[{"id":"nct06780839","kind":"trial","name":"Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD","route":"/trials/nct06780839/"},{"id":"nct02767804","kind":"trial","name":"eXalt3","route":"/trials/nct02767804/"},{"id":"nct07448116","kind":"trial","name":"Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.","route":"/trials/nct07448116/"},{"id":"nct06955325","kind":"trial","name":"Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations","route":"/trials/nct06955325/"}]}}