Chronic Myeloid Leukemia Knowledge Centre

Imatinib- Glivec

Efficacy of Glivec

Glivec is the standard of care in Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) with proven efficacy and longevity. With more than 5 years of follow-up data in the IRIS study, Glivec has consistently achieved and maintained exceptional rates of response. No other drug for CML has established as proven and durable a track record of efficacy and safety as Glivec.

Few drugs have succeeded to the extent that Glivec has in fundamentally changing the natural history of a disease.

Glivec is confirmed as the standard first-line therapy for all CML patients by clinical studies with 5-year follow-up.^1-4

• An 89% overall survival rate at 5 years with Glivec exceeds that of all other CML therapies, with <5% of deaths related to CML.
• An estimated 98% of patients in chronic-phase CML have had a best response of CHR, and an estimated 92% of patients have had a best response of major cytogenetic response with Glivec
• Late responses to Glivec occur and responses are durable.
• Annual risk of progression is decreasing with time.
  • The annual rate of progression to advanced phases of CML (accelerated phase/blast crisis) at year 5 declined to 0.6% (from 1.5% in year 1).
  • Increasing the daily dose of Glivec to 600 or 800 mg may be considered for patients in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropaenia or thrombocytopaenia in certain circumstances, including disease progression, failure to achieve response within prespecified time points, or loss of response (refer to SmPC for further details).⁴
• Overall risk of progression to advanced phase is low and is associated with the degree of response, regardless of when achieved.

Treatment with Glivec in newly diagnosed and untreated paediatric patients with chronic-phase CML is tolerated well and produces cytogenetic response rates comparable to the results observed in adults.^1,5

References:
1. Glivec Summary of Product Characteristics [SMPC]. Basel, Switzerland: Novartis Pharma AG; 2006.
2. Druker BJ, Guilhot F, O'Brien S, Larson RA, on behalf of the IRIS. Long-term benefits of imatinib (IM) for patients newly diagnosed with chronic myelogenous leukemia in chronic phase (CML-CP): the 5-year update from the IRIS study [abstract]. J Clin Oncol. 2006;24:338s. Abstract 6506. Oral presentation.
3. Druker BJ, Guilhot F, O'Brien SG, et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med. 2006;355:2408-2417.
4. Baccarani M, Guilhot F, Larson RA, G. OBS, Druker B, IRIS obot. on behalf of the IRIS Study Group. Outcomes by cytogenetic and molecular response at 12 and 18 months of imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CP) in the IRIS trial [abstract]. Blood. 2006;108:606a. Abstract 2138.
5. Champagne MA, Fu C, Chang M, et al. Imatinib in children with newly diagnosed chronic phase chronic myelogenous leukemia (CP CML): AAML0123 COG study [abstract]. Blood. 2006;108:607a. Abstract 2140.

Developed in partnership with Novartis Oncology by EPG Online