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About Gleevec

First approved by the Food and Drug Administration (FDA) in 2001, GLEEVEC® (imatinib mesylate) is a unique treatment for certain forms of cancer. It works by targeting, and turning off, specific proteins in cancer cells that cause the cancer cells to grow and multiply. GLEEVEC® targets one cancer protein that causes Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) and another cancer protein, called KIT, that is the suspected cause of gastrointestinal stromal tumor (GIST). However, GLEEVEC® can also target other proteins not involved in causing Ph+ CML or KIT-positive GIST.

GLEEVEC (imatinib mesylate) tablets are indicated for:

  • Newly diagnosed adult and pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase
  • Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in the chronic phase (CP) after failure of interferon-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-PDGFRα fusion kinase and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown
  • Adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP)
  • Patients with Kit (CD117)–positive gastrointestinal stromal tumors (GIST) that are cancerous, cannot be surgically removed, and/or have spread to other parts of the body
  • Adult patients after surgery who have had their Kit (CD117)–positive GISTs completely removed. Approval is based on survival without a return of cancer (recurrence-free survival) with a median follow-up of 14 months. Clinical benefit has not been demonstrated by a long-term effect on recurrence-free survival or survival