{"entity":{"id":"crizotinib","kind":"drug","name":"Crizotinib","aka":[],"tldr":"Crizotinib was the first ALK inhibitor, approved four years after ALK fusions were found in lung cancer; it was also the first drug for ROS1 lung cancer and for ALK-positive lymphoma and inflammatory myofibroblastic tumour in children.","summary":"PROFILE 1007/1014 established it over chemotherapy in ALK+ NSCLC (2011 accelerated, 2013 full); ROS1 approval 2016 (PROFILE 1001, 72% response). Superseded first line by alectinib, brigatinib and lorlatinib (poor CNS penetration). Paediatric approvals for ALK+ ALCL (2021) and IMT (2022). Visual disturbance, oedema, hepatotoxicity.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Crizotinib","links":[{"label":"PROFILE 1014 (NEJM 2014)","url":"https://doi.org/10.1056/NEJMoa1408440"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=crizotinib"},{"label":"NICE TA1021: crizotinib for treating ROS1-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1021"}],"tags":["gap-fill"],"related":["alk-fusion","ros1-fusion"],"cancers":["nsclc","peripheral-t-cell-lymphoma","sarcoma","alk-positive-nsclc","ros1-positive-nsclc","met-altered-nsclc","lung-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk","ros1","met"],"drugs":[],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["gene-fusion","oncogene-addiction"],"trials":["nct02767804","nct06564324","nct05987332","nct03947385","nct04603807","nct06140836","profile-1014","profile-1001-ros1"],"people":[],"bottlenecks":[],"keyPapers":["paper-solomon-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"brand":"Xalkori","modality":"Small-molecule ALK/ROS1/MET TKI (first generation)","mechanism":"ATP-competitive inhibitor of ALK, ROS1 and MET kinases.","approvals":[{"region":"US","year":2011,"indication":"ALK-positive metastatic NSCLC"},{"region":"US","year":2016,"indication":"ROS1-positive metastatic NSCLC"},{"region":"US","year":2021,"indication":"Relapsed ALK-positive ALCL in patients 1-21 years"},{"region":"US","year":2022,"indication":"ALK-positive inflammatory myofibroblastic tumour"},{"region":"EU","year":2012,"indication":"Conditional Oct 2012; full approval 2015"},{"region":"England (NICE)","year":2024,"indication":"ROS1-positive advanced non-small-cell lung cancer in patients who have not had a ROS1 inhibitor","note":"TA1021, published 4 December 2024; NICE asks that the least expensive of crizotinib and entrectinib is used."}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2011-08-26","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test"},{"date":"2013-11-20","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2011 converted to traditional approval 2.2 years after it was granted.","indication":"Locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test"}]},"route":"/drugs/crizotinib/","neighbours":{"biomarker":[{"id":"alk-fusion","kind":"biomarker","name":"ALK fusion (ALK-positive)","route":"/biomarkers/alk-fusion/"},{"id":"ros1-fusion","kind":"biomarker","name":"ROS1 fusion (ROS1-positive)","route":"/biomarkers/ros1-fusion/"}],"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"inflammatory-myofibroblastic-tumour","kind":"cancer","name":"Inflammatory myofibroblastic tumour (IMT)","route":"/cancers/inflammatory-myofibroblastic-tumour/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"},{"id":"ros1-positive-nsclc","kind":"cancer","name":"ROS1-positive non-small-cell lung cancer","route":"/cancers/ros1-positive-nsclc/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"},{"id":"pulmonary-sarcomatoid-carcinoma","kind":"cancer","name":"Sarcomatoid carcinoma of the lung","route":"/cancers/pulmonary-sarcomatoid-carcinoma/"},{"id":"uterine-sarcoma","kind":"cancer","name":"Uterine sarcoma","route":"/cancers/uterine-sarcoma/"}],"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/"},{"id":"met","kind":"target","name":"MET","route":"/targets/met/"},{"id":"ron","kind":"target","name":"RON receptor (MST1R)","route":"/targets/ron/"},{"id":"ros1","kind":"target","name":"ROS1","route":"/targets/ros1/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. 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