Prospective single-center study of chronic myeloid leukemia in chronic phase: switching from branded imatinib to a copy drug and back

Abstract

Imatinib (Glivec^®/Gleevec^®) has shown long-term efficacy and safety in randomized trials. No large-scale studies have prospectively assessed the benefit–risk profile of an imatinib copy drug. We prospectively evaluated the response of patients with chronic myeloid leukemia in chronic phase in one institution. Patients with a complete hematologic response (n = 126) switched from branded imatinib to an imatinib copy drug. Subsequently, all patients switched back to the branded imatinib. Many patients in this study had a loss of hematologic response and tolerability issues with the imatinib copy drug. Hematologic response and tolerability improved upon retreatment with branded Glivec.

Keywords::

• Imatinib
• copy drug
• chronic myeloid leukemia
• Glivec/Gleevec
• complete hematologic response
• Imatib

Acknowledgements

Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. We thank Pamela Tuttle, PhD (Articulate Science, LLC) for medical editorial assistance with the manuscript.

Potential conflict of interest:

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