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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.
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.
Demethylated by adenosine deaminase to ara-G, which accumulates as ara-GTP preferentially in T lymphoblasts and is incorporated into DNA, blocking synthesis.
1.Nelarabine slips into a pocket on its target.
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Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia following at least 2 chemotherapy regimens
Confirmed: the accelerated approval of 2005 converted to traditional approval 13.8 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2005 | Relapsed or refractory T-ALL and T-LBL after at least two regimens (accelerated) |
| EU | 2007 | T-ALL and T-LBL after at least two regimens (Atriance) |
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Query for this drug: (TITLE:"Nelarabine" OR ABSTRACT:"Nelarabine" OR TITLE:"Arranon" OR ABSTRACT:"Arranon" OR TITLE:"Atriance" OR ABSTRACT:"Atriance") 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 Nelarabine, not a curated reading list.
Shares AALL0434: nelarabine in newly diagnosed T-cell acute lymphoblastic leukaemia in children and young adults, COG AALL0434, High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Acute lymphoblastic leukaemia.
Shares High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Novartis, Acute lymphoblastic leukaemia.
Shares DNA polymerase alpha (POLA1), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Acute lymphoblastic leukaemia, Cytotoxic chemotherapy.
Shares High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Novartis, Acute lymphoblastic leukaemia.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Acute lymphoblastic leukaemia.