Table 1

Drugs approved by the FDA for treatment of acute leukemia and related diseases

DrugIndication
Regular approval  
    Asparaginase Treatment of ALL 
    Cytarabine Remission induction in AML in adults and children 
    Daunorubicin Remission induction in AML in adults and ALL in adults and children 
    Idarubicin Treatment of AML in adults 
    6-Mercaptopurine Remission induction and maintenance of ALL 
    Mitoxantrone Initial therapy of AML 
    Teniposide Induction therapy in recurrent ALL in children 
    Thioguanine Treatment of AML 
    Vincristine Treatment of acute leukemia 
    Tretinoin Remission induction in recurrent APL 
    Arsenic trioxide Remission induction, consolidation in recurrent APL 
    Dasatinib Philadelphia chromosome-positive ALL in adults resistant or intolerant to prior therapy 
    Azacitidine Treatment of myelodysplasia 
    Decitabine Treatment of myelodysplasia 
    Lenalidomide Treatment of low/intermediate-1 risk MDS associated with 5q– 
Accelerated approval  
    Gemtuzumab ozogamicin Treatment of CD33+ AML in first relapse in adults ≥ 60 y not candidates for chemotherapy 
    Clofarabine Treatment of childhood ALL recurrent after ≥ 2 prior therapies 
    Nelarabine T-cell ALL recurrent after ≥ 2 therapies in children and adults 
DrugIndication
Regular approval  
    Asparaginase Treatment of ALL 
    Cytarabine Remission induction in AML in adults and children 
    Daunorubicin Remission induction in AML in adults and ALL in adults and children 
    Idarubicin Treatment of AML in adults 
    6-Mercaptopurine Remission induction and maintenance of ALL 
    Mitoxantrone Initial therapy of AML 
    Teniposide Induction therapy in recurrent ALL in children 
    Thioguanine Treatment of AML 
    Vincristine Treatment of acute leukemia 
    Tretinoin Remission induction in recurrent APL 
    Arsenic trioxide Remission induction, consolidation in recurrent APL 
    Dasatinib Philadelphia chromosome-positive ALL in adults resistant or intolerant to prior therapy 
    Azacitidine Treatment of myelodysplasia 
    Decitabine Treatment of myelodysplasia 
    Lenalidomide Treatment of low/intermediate-1 risk MDS associated with 5q– 
Accelerated approval  
    Gemtuzumab ozogamicin Treatment of CD33+ AML in first relapse in adults ≥ 60 y not candidates for chemotherapy 
    Clofarabine Treatment of childhood ALL recurrent after ≥ 2 prior therapies 
    Nelarabine T-cell ALL recurrent after ≥ 2 therapies in children and adults 
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