Deleterious effects of non-branded versions of imatinib used for the treatment of patients with chronic myeloid leukemia in chronic phase: a case series on an escalating issue impacting patient safety

Abstract

Glivec (imatinib mesylate) has changed the natural history of chronic-phase chronic myeloid leukemia (CML-CP), transforming it into a long-term and manageable disease. At our institution, we treat over 100 patients with CML-CP per year, typically with first-line imatinib therapy. Recently, several healthcare systems and insurance providers have substituted non-branded versions of imatinib that have not demonstrated efficacy or safety comparable to that of imatinib. Here, we analyzed a series of 12 patients who were exposed to non-branded versions of imatinib. Following the switch from branded imatinib to non-branded imatinib, 5/8 patients (63%) experienced treatment failure and 6/8 (75%) experienced severe and recurrent adverse events. All four patients treated with first-line non-branded imatinib therapy experienced resistance or a suboptimal response, and 3/4 (75%) also experienced intolerance. Overall in this small patient cohort, all 12 patients treated with non-branded imatinib therapies failed to meet common treatment milestones and/or suffered recurrent and severe adverse events.

Keywords::

• Chronic myeloid leukemia
• imatinib
• BCR–ABL

Acknowledgements

Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. We thank Michael Mandola, PhD (Articulate Science), for his medical editorial assistance with this manuscript.

Potential conflict of interest:

Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.