{"entity":{"id":"fludarabine","kind":"drug","name":"Fludarabine","aka":[],"tldr":"Fludarabine is a chemotherapy infusion for chronic lymphocytic leukaemia. It anchored the FCR regimen that was the first to give long remissions, and today it is used above all to prepare patients for CAR-T cells and transplants.","summary":"Fludarabine phosphate was approved in 1991 for B-cell CLL that has not responded to, or has progressed during, at least one alkylating-agent regimen, on single-arm studies from MD Anderson and SWOG. Its lasting importance is in combinations: fludarabine, cyclophosphamide and rituximab (FCR; CLL8) was the first regimen to improve overall survival in CLL and remains an option for fit patients with mutated IGHV, while fludarabine plus cyclophosphamide is the standard lymphodepletion before every approved CAR-T product and part of reduced-intensity conditioning for allogeneic transplant. Prolonged T-cell depletion brings opportunistic infection, and autoimmune haemolysis is a class hazard; neurotoxicity occurs at high doses.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Fludarabine","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=fludarabine"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/fludarabinephosphate"}],"tags":["nci-list","generic"],"related":[],"cancers":["cll"],"sections":[],"technologies":["cytotoxic-chemotherapy","car-t","allogeneic-hsct"],"targets":[],"drugs":[],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06413498","nct06045806","nct05371093","nct07486089","nct06480565","nct04792489","nct06253663","nct05826535","nct07589543","nct07510815","nct03907852","nct07149857","nct07617805","nct06119685","nct07480928","nct04245839","nct06093841","nct04268706","nct07627711","nct04836507","nct07500220","nct07627698","nct07641036","nct07551349","nct04416984","nct07523529","nct07502287","nct07589530","nct05624554","nct03591510","nct07598955","nct07015242","nct06500273","nct03182244","nct03793478","nct07551362"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Fludara (historic)","modality":"Purine nucleotide analogue (antimetabolite)","mechanism":"Dephosphorylated to 2-fluoro-ara-A and rephosphorylated to the triphosphate, which inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase and is incorporated into DNA.","approvals":[{"region":"US","year":1991,"indication":"B-cell chronic lymphocytic leukaemia after at least one alkylating-agent regimen"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2008-12-18","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimen"},{"date":"2011-12-31","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 3.0 years after its accelerated approval.","indication":"For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimen"}]},"route":"/drugs/fludarabine/","neighbours":{"cancer":[{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"},{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-treatment-naive","kind":"cancer","name":"Chronic lymphocytic leukaemia, first treatment","route":"/cancers/cll-treatment-naive/"}],"technology":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic 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