Generic Imatinib in Chronic Myeloid Leukemia: Survival of the cheapest

Abstract Introduction The patent expiration of Imatinib mesylate (Gleevec, ®Novartis) on February 1, 2016, has brought the focus back on generic versions of the drug, and an opportunity to provide a safe and cost effective alternative. Objectives To determine the molecular and cytogenetic responses, survival endpoints (event free survival (EFS), failure free survival (FFS), transformation free survival (TFS), overall survival (OS), and safety of innovator and generic brands of imatinib. Materials and Methods In this retrospective analysis, data from 1,812 patients with chronic myeloid leukemia (CML) treated with frontline Imatinib mesylate (Innovator/Generic) at a single institution between 2008 and 2014 is included. Of these, 445 were excluded due to inadequate data and follow up and a further 156 were excluded as they were in either accelerated phase or blast crisis at diagnosis. Thus, data from 1,067 patients who were treated with Gleevec (®Novartis), and 144 patients with Veenat (®NATCO) was available for analysis, and included in the study. Results There was no significant difference in EFS (p=0.05), FFS (p=0.07), TFS (p=0.12) or OS (p=0.24) between the two groups. The frequency of reported non-hematological adverse events and hematological adverse events was comparable between the study groups. Conclusion: The findings of the present study showed comparable efficacy and safety of the generic and innovator versions of imatinib in the treatment of patients with CML.