GLEEVEC FAQs—Product Information
What is the generic name of GLEEVEC?
- The generic name of GLEEVEC® is imatinib mesylate.
What is GLEEVEC and what is the approved indication?
- GLEEVEC is a therapy that targets the main cause of Chronic Myeloid Leukemia (CML)—the Philadelphia chromosome. GLEEVEC is indicated for the treatment of: Newly diagnosed adult patients with Philadelphia chromosome–positive CML (Ph+ CML) in chronic phase
- Patients with Philadelphia chromosome–positive CML in blast crisis, accelerated phase, or in chronic phase after failure on interferon-alpha therapy
- Pediatric patients with Ph+ CML in chronic phase who are newly diagnosed or whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy
- There are no controlled trials in pediatric patients demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
- GLEEVEC is also indicated for:
- Adult patients with relapsed or refractory Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL)
- Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
- 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 (mutational analysis or FISH demonstration of CHIC2 allele deletion) 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 unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)
- Adjuvant treatment of adult patients following resection of KIT (CD117) positive GIST
When was GLEEVEC approved?
- The Food and Drug Administration approved GLEEVEC on May 10, 2001, for use in the United States for the treatment of patients with Philadelphia–positive chronic myeloid leukemia (Ph+ CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
- As of February 1, 2002, the FDA granted Novartis approval of GLEEVEC for the treatment of patients with KIT (CD117)–positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
- As of December 20, 2002, GLEEVEC was approved for newly diagnosed adult patients with Ph+ CML in blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy.
- As of May 21, 2003, GLEEVEC was approved for the treatment of pediatric patients with Ph+ CML, whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy.
- As of October 19, 2006, GLEEVEC was approved for 5 additional indications:
Adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP)
- As of December 19, 2008, GLEEVEC was approved for the adjuvant treatment of adult patients following resection of KIT (CD117)–positive GIST. 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.
How much will GLEEVEC cost?
- There is usually quite a bit of variability on prices from one pharmacy to another. It is best to check the price with your pharmacy of choice. Financial assistance is available to many patients through the My GIST Circle Copay Card, or by calling the GLEEVEC Reimbursement Hotline at 1-877-GLEEVEC (1-877-453-3832).
Is GLEEVEC covered by insurance?
- Many insurance companies cover GLEEVEC, but patients should contact their personal health insurance carrier to determine their coverage for GLEEVEC. Click here to review more of the available financial assistance options.