{"entity":{"id":"cpx-351","kind":"drug","name":"CPX-351 (liposomal daunorubicin-cytarabine)","aka":[],"tldr":"The two old chemotherapy drugs packed together into tiny fat bubbles at a fixed ratio, which doubled five-year survival in older adults with high-risk AML.","summary":"Fixed 5:1 molar ratio of cytarabine to daunorubicin in liposomes that persist in marrow. Study 301 (n=309, age 60-75, therapy-related or MDS-related AML): median OS 9.56 vs 5.95 months (HR 0.69), 5-year OS 18% vs 8%; benefit concentrated in patients bridged to transplant. Approved 2017 (adults) and 2021 (paediatric). Being tested in younger high-risk patients and MDS.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Daunorubicin/cytarabine","links":[{"label":"5-year results (Lancet Haematology 2021)","url":"https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(21)00134-4/abstract"}],"tags":[],"related":[],"cancers":["aml","aml-secondary"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["jazz"],"institutions":[],"pathways":[],"terms":[],"trials":["cpx-351-301"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Vyxeos","modality":"Liposomal cytotoxic formulation","mechanism":"Liposomal co-delivery maintains the synergistic drug ratio in leukaemic blasts and prolongs exposure.","approvals":[{"region":"US","year":2017,"indication":"Newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, adults"},{"region":"US","year":2021,"indication":"Paediatric patients ≥1 year"}],"mechanismSteps":["Liposomes circulate for days and accumulate in bone marrow","Blasts take up intact liposomes preferentially over normal progenitors","Cytarabine and daunorubicin are released together at the synergistic 5:1 ratio","DNA chain termination plus topoisomerase II poisoning kill blasts","Deeper remissions enable more patients to reach transplant"],"dosing":{"route":"IV over 90 minutes","schedule":"Induction days 1, 3, 5 (daunorubicin 44 mg/m² + cytarabine 100 mg/m² per dose); second induction days 1, 3; consolidation at reduced dose","monitoring":"Counts, cardiac function; do not substitute for conventional 7+3 dosing","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vyxeos"},"toxicity":[{"event":"Prolonged cytopenias","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vyxeos","note":"Longer neutrophil and platelet recovery than 7+3"},{"event":"Haemorrhage","anyGradePct":74,"note":"Study 301, any grade"},{"event":"Febrile neutropenia","anyGradePct":68},{"event":"Cardiotoxicity","note":"Cumulative anthracycline exposure counts"}],"access":[],"regulatoryEvents":[{"date":"2017-08-03","type":"approval","region":"US","note":"Adults"},{"date":"2021-03-30","type":"label-change","region":"US","note":"Paediatric expansion"}]},"route":"/drugs/cpx-351/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"},{"id":"aml-secondary","kind":"cancer","name":"Secondary and therapy-related acute myeloid leukaemia","route":"/cancers/aml-secondary/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"company":[{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"}],"trial":[{"id":"nct03416179","kind":"trial","name":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia","route":"/trials/nct03416179/"},{"id":"nct04293562","kind":"trial","name":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","route":"/trials/nct04293562/"},{"id":"cpx-351-301","kind":"trial","name":"CPX-351 Study 301","route":"/trials/cpx-351-301/"},{"id":"myelomatch","kind":"trial","name":"myeloMATCH","route":"/trials/myelomatch/"}],"term":[{"id":"aml-myelodysplasia-related","kind":"term","name":"AML with myelodysplasia-related gene mutations (AML-MR)","route":"/terms/aml-myelodysplasia-related/"}],"drug":[{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"daunorubicin","kind":"drug","name":"Daunorubicin","route":"/drugs/daunorubicin/"}]}}