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U.S. Department of Health and Human Services

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FDA approves imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications

On October 19, 2006, the U. S. Food and Drug Administration (FDA) granted approval to imatinib mesylate (Gleevec, Novartis Pharmaceuticals) as a single agent for the treatment of dermatofibrosarcoma protuberans (DFSP), myelodysplastic/ myeloproliferative diseases ( MDS/MPD), aggressive systemic mastocytosis (ASM), hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL), and relapsed/refractory Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL).

The approved new indications and recommended dosages for each specific indication follows:

Gleevec is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic DFSP.  Recommended dose: 800 mg/day.

Gleevec is indicated for the treatment of adult patients with MDS/MPD associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements.  Recommended dose: 400 mg/day.

Gleevec is indicated for the treatment of adult patients with ASM without the D816V c-Kit mutation or with unknown c-Kit mutational status. Recommended dose: 400 mg for patients without the D816V c-Kit mutation or with c-Kit mutational status unknown. Patients with ASM associated with eosinophilia the starting dose is 100 mg/day.

Gleevec is indicated for the treatment of HES/CEL.  The recommended dose of Gleevec for this indication is 400 mg/day.  For HES/CEL patients with demonstrated FIP1L1-PDGFRα fusion kinase, a starting dose of 100 mg/day is recommended.

Gleevec is indicated as a single agent for the treatment of adult patients with relapsed or refractory Ph+ ALL.  Recommended dose: 600 mg/day.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available in Drugs@FDA

 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088, by facsimile 1-800-FDA-0178, by mail, or by using the Form 3500 

 

 

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