title: 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.
authors.affiliation: The National Center of Hematology , Baghdad , Iraq.
authors.forename: Alaa Fadhil
authors.initials: AF
authors.lastname: Alwan
authors.forename: Bassam F
authors.initials: BF
authors.lastname: Matti
authors.forename: Aladdin S
authors.initials: AS
authors.lastname: Naji
authors.forename: Abdulsalam H
authors.initials: AH
authors.lastname: Muhammed
authors.forename: Manal A
authors.initials: MA
authors.lastname: Abdulsahib
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018450:Disease Progression; D057915:Drug Substitution; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D015466:Leukemia, Myeloid, Chronic-Phase / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate
keywords: Glivec/Gleevec; Imatib; Imatinib; chronic myeloid leukemia; complete hematologic response; copy drug