{"entity":{"id":"dasatinib","kind":"drug","name":"Dasatinib","aka":[],"tldr":"Dasatinib is a second-generation BCR::ABL1 pill that, combined with the immunotherapy blinatumomab, can put Ph-positive ALL into deep remission with no chemotherapy at all.","summary":"Approved in CML (2006) and Ph+ ALL (resistant, 2006; paediatric frontline with chemotherapy 2018). The GIMEMA D-ALBA trial (dasatinib induction then blinatumomab) achieved 18-month OS 95% and DFS 88% in adults, launching the chemotherapy-free paradigm; long-term follow-up shows ~75% DFS at 4 years, with IKZF1-plus and T315I as the relapse drivers. Generic since 2024.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Dasatinib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Dasatinib"}],"tags":[],"related":[],"cancers":["all-leukemia","all-paediatric-ph-positive","all-ph-like","cml-chronic-phase"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["bcr-abl","ddr2","abl1"],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":["ph-positive-all"],"trials":["d-alba","nct04971226"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Sprycel","modality":"Small-molecule kinase inhibitor (BCR::ABL1, SRC)","mechanism":"Dual SRC/ABL inhibitor binding active and inactive ABL1 conformations; inactive against T315I.","approvals":[{"region":"US","year":2006,"indication":"CML and Ph+ ALL resistant or intolerant to imatinib"},{"region":"US","year":2018,"indication":"Paediatric Ph+ ALL with chemotherapy"}],"mechanismSteps":["Dasatinib blocks BCR::ABL1 and SRC-family kinases in lymphoblasts","Proliferation and survival signalling stop; blasts clear within weeks","Blinatumomab then recruits T cells to kill residual MRD-level CD19+ cells","Transplant reserved for MRD persistence or high-risk genetics"],"dosing":{"route":"Oral","schedule":"Ph+ ALL: 140 mg once daily (adult); paediatric weight-based; continue through consolidation and maintenance","monitoring":"Pleural effusion, myelosuppression, pulmonary arterial hypertension, QT","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Sprycel"},"toxicity":[{"event":"Pleural effusion","anyGradePct":28,"source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Sprycel","note":"CML long-term data"},{"event":"Myelosuppression","grade3PlusPct":50,"note":"Higher in ALL with chemotherapy"},{"event":"Pulmonary arterial hypertension","note":"Rare, reversible on stopping"}],"access":[],"regulatoryEvents":[{"date":"2006-06-28","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib"},{"date":"2009-05-21","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2006 converted to traditional approval 2.9 years after it was granted.","indication":"Chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib"},{"date":"2010-10-28","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phase"},{"date":"2015-08-12","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2010 converted to traditional approval 4.8 years after it was granted.","indication":"Newly diagnosed adults with Philadelphia chromosome-positive CML in chronic phase"}]},"route":"/drugs/dasatinib/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"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":"mixed-phenotype-acute-leukaemia","kind":"cancer","name":"Mixed-phenotype acute leukaemia","route":"/cancers/mixed-phenotype-acute-leukaemia/"},{"id":"all-ph-like","kind":"cancer","name":"Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL)","route":"/cancers/all-ph-like/"},{"id":"all-paediatric-ph-positive","kind":"cancer","name":"Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)","route":"/cancers/all-paediatric-ph-positive/"}],"technology":[{"id":"rejuv-frontier-senolytics","kind":"technology","name":"Senolytics after cancer treatment","route":"/technologies/rejuv-frontier-senolytics/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"abl1","kind":"target","name":"ABL1","route":"/targets/abl1/"},{"id":"bcr-abl","kind":"target","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/targets/bcr-abl/"},{"id":"ddr2","kind":"target","name":"DDR2 receptor kinase","route":"/targets/ddr2/"},{"id":"epha2","kind":"target","name":"EphA2 receptor","route":"/targets/epha2/"},{"id":"frk","kind":"target","name":"FRK kinase","route":"/targets/frk/"},{"id":"hck","kind":"target","name":"HCK kinase","route":"/targets/hck/"},{"id":"lyn","kind":"target","name":"LYN kinase","route":"/targets/lyn/"},{"id":"ptk6","kind":"target","name":"PTK6 (BRK)","route":"/targets/ptk6/"},{"id":"src","kind":"target","name":"SRC family kinases","route":"/targets/src/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"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":"ph-like-all","kind":"term","name":"Ph-like (BCR::ABL1-like) acute lymphoblastic leukaemia","route":"/terms/ph-like-all/"},{"id":"ph-positive-all","kind":"term","name":"Ph-positive ALL","route":"/terms/ph-positive-all/"},{"id":"philadelphia-chromosome","kind":"term","name":"Philadelphia chromosome (Ph+, BCR::ABL1)","route":"/terms/philadelphia-chromosome/"},{"id":"sokal-elts-scores","kind":"term","name":"Sokal and ELTS risk scores (chronic myeloid leukaemia)","route":"/terms/sokal-elts-scores/"}],"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":"nct02883049","kind":"trial","name":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations","route":"/trials/nct02883049/"},{"id":"d-alba","kind":"trial","name":"D-ALBA (GIMEMA LAL2116)","route":"/trials/d-alba/"},{"id":"dasision","kind":"trial","name":"DASISION","route":"/trials/dasision/"},{"id":"ready-dasatinib","kind":"trial","name":"READY","route":"/trials/ready-dasatinib/"},{"id":"nct05725200","kind":"trial","name":"Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer","route":"/trials/nct05725200/"},{"id":"tapur","kind":"trial","name":"TAPUR (Targeted Agent and Profiling Utilization Registry)","route":"/trials/tapur/"}],"pairing":[{"id":"tki-plus-blinatumomab-ph-all","kind":"pairing","name":"BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL)","route":"/pairings/tki-plus-blinatumomab-ph-all/"}],"idea":[{"id":"idea-transplant-free-ph-all","kind":"idea","name":"Transplant-free Ph-positive ALL for MRD-negative adults","route":"/ideas/idea-transplant-free-ph-all/"}],"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/"}],"person":[{"id":"charles-sawyers","kind":"person","name":"Charles L. Sawyers","route":"/people/charles-sawyers/"}],"paper":[{"id":"paper-dasatinib-vs-imatinib-ph-positive-all-shen-jama-oncol-2020","kind":"paper","name":"Dasatinib versus imatinib with chemotherapy for paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CCCG-ALL-2015)","route":"/key-papers/paper-dasatinib-vs-imatinib-ph-positive-all-shen-jama-oncol-2020/"},{"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/"}],"biomarker":[{"id":"bcr-abl1-transcript","kind":"biomarker","name":"BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR)","route":"/biomarkers/bcr-abl1-transcript/"}]}}