Application Nr Approved Date Route Status External Links
NDA021588 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Gleevec Is A Kinase Inhibitor Indicated For The Treatment Of: Newly Diagnosed Adult And Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ Cml) In Chronic Phase ( 1.1 ) Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ Cml) In Blast Crisis (Bc), Accelerated Phase (Ap), Or In Chronic Phase (Cp) After Failure Of Interferon-Alpha Therapy ( 1.2 ) Adult Patients With Relapsed Or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ All) ( 1.3 ) Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ All) In Combination With Chemotherapy ( 1.4 ) Adult Patients With Myelodysplastic/myeloproliferative Diseases (Mds/mpd) Associated With Platelet-Derived Growth Factor Receptor (Pdgfr) Gene Re-Arrangements As Determined With An Fda-Approved Test ( 1.5 ) Adult Patients With Aggressive Systemic Mastocytosis (Asm) Without The D816v C-Kit Mutation As Determined With An Fda-Approved Test Or With C-Kit Mutational Status Unknown ( 1.6 ) Adult Patients With Hypereosinophilic Syndrome (Hes) And/or Chronic Eosinophilic Leukemia (Cel) Who Have The Fip1l1-Pdgfrα Fusion Kinase (Mutational Analysis Or Fish Demonstration Of Chic2 Allele Deletion) And For Patients With Hes And/or Cel Who Are Fip1l1-Pdgfrα Fusion Kinase Negative Or Unknown ( 1.7 ) Adult Patients With Unresectable, Recurrent And/or Metastatic Dermatofibrosarcoma Protuberans (Dfsp) ( 1.8 ) Patients With Kit (Cd117) Positive Unresectable And/or Metastatic Malignant Gastrointestinal Stromal Tumors (Gist) ( 1.9 ) Adjuvant Treatment Of Adult Patients Following Resection Of Kit (Cd117) Positive Gist ( 1.10 ) 1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ Cml) Newly Diagnosed Adult And Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ Cml) In Chronic Phase. 1.2 Ph+ Cml In Blast Crisis (Bc), Accelerated Phase (Ap) Or Chronic Phase (Cp) After Interferon-Alpha (Ifn) Therapy Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia In Blast Crisis, Accelerated Phase, Or In Chronic Phase After Failure Of Interferon-Alpha Therapy. 1.3 Adult Patients With Ph+ Acute Lymphoblastic Leukemia (All) Adult Patients With Relapsed Or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ All). 1.4 Pediatric Patients With Ph+ Acute Lymphoblastic Leukemia (All) Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ All) In Combination With Chemotherapy. 1.5 Myelodysplastic/myeloproliferative Diseases (Mds/mpd) Adult Patients With Myelodysplastic/myeloproliferative Diseases Associated With Pdgfr (Platelet-Derived Growth Factor Receptor) Gene Re-Arrangements As Determined With An Fda-Approved Test [See Dosage And Administration (2.6)] . 1.6 Aggressive Systemic Mastocytosis (Asm) Adult Patients With Aggressive Systemic Mastocytosis Without The D816v C-Kit Mutation As Determined With An Fda-Approved Test [See Dosage And Administration (2.7)] Or With C-Kit Mutational Status Unknown. 1.7 Hypereosinophilic Syndrome (Hes) And/or Chronic Eosinophilic Leukemia (Cel) Adult Patients With Hypereosinophilic Syndrome And/or Chronic Eosinophilic Leukemia Who Have The Fip1l1-Pdgfrα Fusion Kinase (Mutational Analysis Or Fish Demonstration Of Chic2 Allele Deletion) And For Patients With Hes And/or Cel Who Are Fip1l1-Pdgfrα Fusion Kinase Negative Or Unknown. 1.8 Dermatofibrosarcoma Protuberans (Dfsp) Adult Patients With Unresectable, Recurrent And/or Metastatic Dermatofibrosarcoma Protuberans. 1.9 Kit+ Gastrointestinal Stromal Tumors (Gist) Patients With Kit (Cd117) Positive Unresectable And/or Metastatic Malignant Gastrointestinal Stromal Tumors. 1.10 Adjuvant Treatment Of Gist Adjuvant Treatment Of Adult Patients Following Complete Gross Resection Of Kit (Cd117) Positive Gist.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Imatinib Mesylate IMATINIB MESYLATE ZINC19632618

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