Summary

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• Gleevec (imatinib mesylate) is indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; for the treatment of 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; for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL); for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy; for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements; for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown; for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown; for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP); for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST); and for the adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.
• This summary is based on the review of 10 systematic review(s)/meta-analysis(es). ^[1-10]
• Pediatric Chronic Myeloid Leukemia (CML): Imatinib mesylate (IM) caused significant growth deceleration in children, with a standardized mean difference (SMD) of -0.52 (95% CI: -0.76; -0.28), particularly in studies with less than 3 years of follow-up.
• Unresectable Dermatofibrosarcoma Protuberans (DFSP): Clinical benefit following tyrosine kinase inhibitors (TKI), including imatinib, ranged from 70% to 96%. Radiotherapy showed clinical control or resolution in 90% of cases.
• Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL): The combination of TKIs with chemotherapy likely improved overall survival (OS) and event-free survival (EFS), with dasatinib being superior to imatinib in both OS and EFS.
• Systemic Sclerosis (SSc): Imatinib significantly improved the modified Rodnan skin score (mRSS) with a mean difference (MD) of -3.091 (95% CI: -6.081 to -0.102, p = 0.043), while quality of life scores remained unchanged.
• Hepatotoxicity and Thyroid Toxicity: 12.6% of CML patients experienced hepatotoxicity, with 64.7% of these cases being mild and 28.6% severe, sometimes leading to treatment discontinuation, liver transplantation, or fatal outcomes. Additionally, 8.4% experienced thyroid dysfunction, mostly mild and manageable.
• Anemia in CML: 34% of CML patients treated with imatinib experienced anemia, necessitating monitoring and management.