{"entity":{"id":"nilotinib","kind":"drug","name":"Nilotinib","aka":[],"tldr":"Nilotinib is a second-generation CML pill that produces deeper responses faster than imatinib, at the cost of cardiovascular and metabolic side effects.","summary":"Approved in 2007 for imatinib-resistant CML and in 2010 first line (ENESTnd: higher major molecular response than imatinib without an overall survival difference). Requires fasting dosing, QT monitoring and attention to arterial occlusive events, hyperglycaemia and lipids. Widely used as the bridge to treatment-free remission because of deep responses; generic since 2024 in some markets.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Nilotinib","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=nilotinib"}],"tags":["gap-fill"],"related":["bcr-abl1-transcript"],"cancers":["cml","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["bcr-abl","kit"],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04971226","nct05456191"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tasigna","modality":"Small-molecule BCR-ABL1 TKI (second generation)","mechanism":"ATP-competitive inhibitor of BCR-ABL1 with ~30-fold greater potency than imatinib; also KIT, PDGFR.","approvals":[{"region":"US","year":2007,"indication":"Ph+ CML, chronic or accelerated phase, resistant/intolerant to imatinib"},{"region":"US","year":2010,"indication":"Newly diagnosed Ph+ CML chronic phase"},{"region":"EU","year":2007,"indication":"Ph+ CML"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2007-10-29","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)"},{"date":"2010-06-17","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase"},{"date":"2011-01-14","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2007 converted to traditional approval 3.2 years after it was granted.","indication":"Chronic phase and accelerated phase Philadelphia chromosome positive CML in adults resistant or intolerant to prior therapy that included Gleevec (imatinib)"},{"date":"2015-01-27","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2010 converted to traditional approval 4.6 years after it was granted.","indication":"Newly diagnosed adults with with Philadelphia chromosome-positive CML in chronic phase"}]},"route":"/drugs/nilotinib/","neighbours":{"biomarker":[{"id":"bcr-abl1-transcript","kind":"biomarker","name":"BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR)","route":"/biomarkers/bcr-abl1-transcript/"}],"cancer":[{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"},{"id":"cml-advanced-phase","kind":"cancer","name":"Chronic myeloid leukaemia, accelerated and blast phase","route":"/cancers/cml-advanced-phase/"},{"id":"cml-chronic-phase","kind":"cancer","name":"Chronic myeloid leukaemia, chronic phase","route":"/cancers/cml-chronic-phase/"},{"id":"mucosal-melanoma","kind":"cancer","name":"Mucosal melanoma","route":"/cancers/mucosal-melanoma/"},{"id":"tenosynovial-giant-cell-tumour","kind":"cancer","name":"Tenosynovial giant cell tumour (TGCT)","route":"/cancers/tenosynovial-giant-cell-tumour/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"bcr-abl","kind":"target","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/targets/bcr-abl/"},{"id":"kit","kind":"target","name":"KIT","route":"/targets/kit/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"trial":[{"id":"nct04971226","kind":"trial","name":"A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP","route":"/trials/nct04971226/"},{"id":"nct05456191","kind":"trial","name":"A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)","route":"/trials/nct05456191/"},{"id":"nct03784014","kind":"trial","name":"Molecular Profiling of Advanced Soft-tissue Sarcomas","route":"/trials/nct03784014/"}],"pathway":[{"id":"bcr-abl1-signalling","kind":"pathway","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/pathways/bcr-abl1-signalling/"},{"id":"cml-signalling","kind":"pathway","name":"Chronic myeloid leukaemia (KEGG map)","route":"/pathways/cml-signalling/"}],"paper":[{"id":"paper-iris-imatinib-nejm-2003","kind":"paper","name":"IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia","route":"/key-papers/paper-iris-imatinib-nejm-2003/"}],"term":[{"id":"abl1-kinase-domain-mutations","kind":"term","name":"BCR::ABL1 kinase domain mutations (T315I and others)","route":"/terms/abl1-kinase-domain-mutations/"},{"id":"molecular-response","kind":"term","name":"Molecular response (MMR, MR4, treatment-free remission)","route":"/terms/molecular-response/"},{"id":"qt-prolongation","kind":"term","name":"QT prolongation","route":"/terms/qt-prolongation/"},{"id":"sokal-elts-scores","kind":"term","name":"Sokal and ELTS risk scores (chronic myeloid leukaemia)","route":"/terms/sokal-elts-scores/"}],"institution":[{"id":"seoul-st-marys-hospital","kind":"institution","name":"Seoul St. Mary's Hospital","route":"/institutions/seoul-st-marys-hospital/"}]}}