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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.
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.
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.
1.Fludarabine slips into a pocket on its target.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
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
Withdrawn: the indication came off the label 3.0 years after its accelerated approval.
| Region | Year | Indication |
|---|---|---|
| US | 1991 | B-cell chronic lymphocytic leukaemia after at least one alkylating-agent regimen |
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Query for this drug: (TITLE:"Fludarabine" OR ABSTRACT:"Fludarabine" OR TITLE:"Fludara" OR ABSTRACT:"Fludara" OR TITLE:"historic" OR ABSTRACT:"historic") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fludarabine, not a curated reading list.
Shares Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT), DALY II USA/ MB-CART2019.1 for DLBCL, A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008), Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination and the tag generic.
Shares A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation, Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood, DNA polymerase alpha (POLA1), A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML and the tag generic.
Shares A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation, A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML, Acute myeloid leukaemia in children, Cytotoxic chemotherapy and the tag generic.
Shares A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML, International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia, Acute myeloid leukaemia in children, Cytotoxic chemotherapy and the tag generic.
Shares Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients, Cytotoxic chemotherapy and the tag generic.
Shares Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia, Cytotoxic chemotherapy and the tag generic.
Shares A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML, Cytotoxic chemotherapy and the tag generic.
Shares International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia, Cytotoxic chemotherapy and the tag generic.