The FDA has approved Gleevec (imatinib; Novartis) in combination with chemotherapy to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Imatinib is a tyrosine kinase inhibitor that blocks the proteins that promote the development of cancerous cells.

The safety and efficacy for this new indication was evaluated in a clinical trial that enrolled 92 patients aged >1 year with very high risk ALL. Patients were divided into five treatment groups, with each successive group receiving a greater duration of Gleevec treatment in combination with chemotherapy. Study results showed 70% of patients in the longest-duration treatment group did not experience relapse or death within four-years (event-free survival). Also, patient deaths decreased with increasing duration of Gleevec treatment in combination with chemotherapy.

Gleevec is currently indicated for Kit (CD117) (+) unresectable and/or metastatic malignant GI stromal tumors (GIST), adjuvant treatment of adults following complete gross resection of Kit (CD117) (+) GIST, adults with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown, adults with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP), and blast crisis, accelerated phase or chronic phase Ph+ chronic myeloid leukemia (CML) who have failed interferon-alpha therapy, and children newly diagnosed with Ph+ CML.

Gleevec is available in 100mg and 400mg dosage strength tablets.

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