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.
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.
Fundación Colombiana de Cancerología , Clínica Vida, Medellín , Colombia.
Domingo
D
Saavedra
Fabiola
F
Vizcarra
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001549:Benzamides / Q000008:administration & dosage / Q000009:adverse effects*; D002626:Chemistry, Pharmaceutical; D057915:Drug Substitution; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects*; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate
BCR–ABL; Chronic myeloid leukemia; imatinib