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Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery
Date:8/27/2008

is and the National Cancer Institute (NCI). The study was led by the American College of Surgeons Oncology Group (ACOSOG).

The investigators reported that Gleevec therapy was well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Gleevec. These include nausea, diarrhea and swelling (edema)(3).

About gastrointestinal stromal tumors (GIST)

Gastrointestinal stromal tumors (GIST) belong to a group of cancers known as soft tissue sarcomas. They are the most common sarcomas and can be found most often in the stomach and small intestine. The incidence of GIST is estimated to be 4,500 - 6,000 new cases per year in the US (15-20 cases per million population)(5), of which more than 90% are kit-positive(6). Kit -- also known as CD117 -- is a protein that, when mutated, has been identified as one of the major causes of GIST.

About Gleevec

Gleevec(R) (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. Follow-up is limited to 5 years. Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha (IFN-alpha) therapy; adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL); adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements; adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-KIT mutation or with c-KIT mutational status unknown; adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1- PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-
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SOURCE Novartis
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