{"entity":{"id":"nelarabine","kind":"drug","name":"Nelarabine","aka":["Atriance"],"tldr":"Nelarabine (Arranon) is an infusion for T-cell acute lymphoblastic leukaemia and lymphoma that has come back after at least two other treatments; it is now also added to first-line therapy for children with T-cell leukaemia.","summary":"Nelarabine received accelerated FDA approval in October 2005 for T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma that has not responded to or has relapsed after at least two chemotherapy regimens, on phase 2 studies in adults (complete remission in about a fifth) and children; the EU authorised Atriance in 2007. The Children's Oncology Group AALL0434 trial later showed that adding nelarabine to frontline therapy improved disease-free survival in newly diagnosed T-ALL, and it is now standard in paediatric protocols. Neurotoxicity, including somnolence, peripheral neuropathy and Guillain-Barre-like demyelination, carries a boxed warning.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Nelarabine","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=nelarabine"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/nelarabine"},{"label":"EPAR (Atriance)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/atriance"}],"tags":["nci-list"],"related":[],"cancers":["all-leukemia","all-paediatric-high-risk","all-paediatric-relapsed"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["novartis","sandoz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aall0434-nelarabine-t-all-dunsmore-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"brand":"Arranon","modality":"Purine nucleoside prodrug (antimetabolite)","mechanism":"Demethylated by adenosine deaminase to ara-G, which accumulates as ara-GTP preferentially in T lymphoblasts and is incorporated into DNA, blocking synthesis.","approvals":[{"region":"US","year":2005,"indication":"Relapsed or refractory T-ALL and T-LBL after at least two regimens (accelerated)"},{"region":"EU","year":2007,"indication":"T-ALL and T-LBL after at least two regimens (Atriance)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2005-10-28","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens"},{"date":"2019-07-31","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2005 converted to traditional approval 13.8 years after it was granted.","indication":"Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens"}]},"route":"/drugs/nelarabine/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-high-risk","kind":"cancer","name":"High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)","route":"/cancers/all-paediatric-high-risk/"},{"id":"all-paediatric-relapsed","kind":"cancer","name":"Relapsed and refractory acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-relapsed/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"},{"id":"sandoz","kind":"company","name":"Sandoz","route":"/companies/sandoz/"}],"paper":[{"id":"paper-aall0434-nelarabine-t-all-dunsmore-jco-2020","kind":"paper","name":"AALL0434: nelarabine in newly diagnosed T-cell acute lymphoblastic leukaemia in children and young adults","route":"/key-papers/paper-aall0434-nelarabine-t-all-dunsmore-jco-2020/"}],"target":[{"id":"pola1","kind":"target","name":"DNA polymerase alpha (POLA1)","route":"/targets/pola1/"}],"trial":[{"id":"aall0434","kind":"trial","name":"COG AALL0434","route":"/trials/aall0434/"}]}}