A multicenter prospective study on efficacy and safety of imatinib generics: A report from Polish Adult Leukemia Group imatinib generics registry.

Abstract

The efficacy and safety of imatinib generics were not studied and reported on larger cohort of patients yet. We report on efficacy and safety of imatinib generics in 726 chronic myeloid leukemia patients in chronic phase who completed one-year observation, prospectively assessed within Polish Adult Leukemia Group imatinib generics registry. In 99 previously untreated patients the rate of early molecular response achieved at 3 months and major molecular response achieved at 12 months was 65.7% and 53.4% respectively. Complete cytogenetic response at 6 months was achieved in 55.4% of patients. In 627 patients switched from branded to generic imatinib the molecular response was sustained in 64.8%, worsened in 15% and improved in 19% of them. Complete cytogenetic response, major molecular response and MR4,5 were lost in 0.3%, 1.3% and 10.3%, respectively. Hematologic toxicity (grade 3 or 4) and non-hematologic toxicity (any grade) occurred in 3% and 40% of 99 previously untreated patients and in 0.2% and 14.4% of "switched" patients, respectively. In one-year observation the efficacy and safety of tested imatinib generics are not inferior to branded imatinib. No increased switching rate from first to second generation tyrosine kinase inhibitors was noticed This article is protected by copyright. All rights reserved.