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:
Glivec/Gleevec; Imatib; Imatinib; chronic myeloid leukemia; complete hematologic response; copy drug.
Publication types
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Adult
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Aged
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use*
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Benzamides / administration & dosage
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Benzamides / adverse effects
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Benzamides / therapeutic use
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Disease Progression
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Drug Substitution
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Female
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Humans
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Imatinib Mesylate
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Leukemia, Myeloid, Chronic-Phase / diagnosis
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Leukemia, Myeloid, Chronic-Phase / drug therapy*
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Male
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Middle Aged
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Piperazines / administration & dosage
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Piperazines / adverse effects
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Piperazines / therapeutic use
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Prospective Studies
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Pyrimidines / administration & dosage
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Pyrimidines / adverse effects
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Pyrimidines / therapeutic use
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Treatment Outcome
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Young Adult
Substances
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Antineoplastic Agents
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Benzamides
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Piperazines
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Pyrimidines
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Imatinib Mesylate