A multicenter prospective study on efficacy and safety of imatinib generics: A report from Polish Adult Leukemia Group imatinib generics registry

Sacha, Tomasz; Góra‐Tybor, Joanna; Szarejko, Monika; Bober, Grazyna; Grzybowska–Izydorczyk, Olga; Niesiobedzka-Krezel, Joanna; Dudziński, Marek; Wasilewska, Ewa; Myśliwiec, Krzysztof; Gil, Justyna; Gniot, Michał; Pietkun, Iwona; Mędraś, M; Hołojda, Jadwiga; Wącław, Joanna; Giannopoulos, Krzysztof

doi:10.1002/ajh.24748

Cited by 23 publications

(19 citation statements)

References 5 publications

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“…It may allow the achievement of an optimal response at a lower cost than standard‐dose dasatinib. Recently, generic formulations of imatinib became available, although at a higher cost than expected . Despite the availability of 4 imatinib generics in the United States in 2017, the average wholesale price of a year of any generic imatinib is $110,000 versus $140,000 or more for patented imatinib.…”

Section: Discussionmentioning

confidence: 99%

Early results of lower dose dasatinib (50 mg daily) as frontline therapy for newly diagnosed chronic‐phase chronic myeloid leukemia

Naqvi

Jabbour

Skinner

et al. 2018

Cancer

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Section: Discussionmentioning

confidence: 99%

Early results of lower dose dasatinib (50 mg daily) as frontline therapy for newly diagnosed chronic‐phase chronic myeloid leukemia

Naqvi

Jabbour

Skinner

et al. 2018

Cancer

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“…Sacha et al reported the efficacy and safety of GI in 726 patients with CML in chronic phase who completed a 1‐year observation, prospectively assessed in the Polish Adult Leukemia Group imatinib generics registry . In 627 patients who switched from BI to GI, the molecular response (MR) was sustained in 64.8%, worsened in 15%, and improved in 19%.…”

Section: Introductionmentioning

confidence: 90%

“…with CML in chronic phase who completed a 1-year observation, prospectively assessed in the Polish Adult Leukemia Group imatinib generics registry. 21 In 627 patients who switched from BI to GI, the molecular response (MR) was sustained in 64.8%, worsened in 15%, and improved in 19%. CCyR, MMR, and MR4.5 (ratio BCR-ABL1/ABL1 = 0.0032%) were lost in 0.3%, 1.3%, and 10.3% of patients, respectively.…”

Section: Sacha Et Al Reported the Efficacy And Safety Of Gi In 726 Pamentioning

confidence: 99%

“…No increase in the switching rate from BI to GI was noted. 21 In another clinical study conducted in Quebec and reported recently as an abstract, 22 167 adult patient pairs were included in a matched cohort study to compare persistence of GI or BI treatment over nearly 4 years of FU. Matched pairs were followed until a switch in therapy, death, withdrawal of consent, or the end of the study.…”

Section: Sacha Et Al Reported the Efficacy And Safety Of Gi In 726 Pamentioning

confidence: 99%

“…During the 1‐year observation period, the efficacy and safety of GI were not found to be inferior to that of BI. No increase in the switching rate from BI to GI was noted …”

Section: Introductionmentioning

confidence: 99%

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Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

Suttorp¹,

Metzler

Millot³

et al. 2018

Pediatric Blood & Cancer

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Since the patent for imatinib has expired, the role of generic imatinib (GI) in the management of Philadelphia chromosome-positive (Ph+) leukemia in pediatric patients has had ongoing discussion. Some studies in adults demonstrated that equivalent doses of GI and branded imatinib (BI) result in comparable plasma concentrations and clinical efficacy. However, other studies found that GI users are more likely to stop imatinib, with intolerance and decreased persistence as the main causes. Economic factors also heavily influence GI selection. This article aims to review the present knowledge to support further discussion on the role of GI in the management of pediatric Ph+ leukemia.

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Chronic myeloid leukemia: 2018 update on diagnosis, therapy and monitoring

2018

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CML is characterized by a balanced genetic translocation, t(9;22)(q34;q11.2), involving a fusion of the Abelson gene (ABL1) from chromosome 9q34 with the breakpoint cluster region (BCR) gene on chromosome 22q11.2. This rearrangement is known as the Philadelphia chromosome. The molecular consequence of this translocation is the generation of a BCR-ABL1 fusion oncogene, which in turn translates into a BCR-ABL1 oncoprotein. Frontline therapy: Four tyrosine kinase inhibitors (TKIs), imatinib, nilotinib, dasatinib, and bosutinib are approved by the United States Food and Drug Administration for first-line treatment of patients with newly diagnosed CML in chronic phase (CML-CP). Clinical trials with second generation TKIs reported significantly deeper and faster responses; this has not translated into improved long-term survival, because of the availability of effective salvage therapies. Salvage therapy: For patients who fail frontline therapy, second-line options include second and third generation TKIs. Second and third generation TKIs, although potent and selective, exhibit unique pharmacological profiles and response patterns relative to different patient and disease characteristics, such as patients' comorbidities, disease stage, and BCR-ABL1 mutational status. Patients who develop the T315I "gatekeeper" mutation display resistance to all currently available TKIs except ponatinib. Allogeneic stem cell transplantation remains an important therapeutic option for patients with CML-CP who have failed at least 2 TKIs, and for all patients in CML advanced phases.

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A multicenter prospective study on efficacy and safety of imatinib generics: A report from Polish Adult Leukemia Group imatinib generics registry

Cited by 23 publications

References 5 publications

Early results of lower dose dasatinib (50 mg daily) as frontline therapy for newly diagnosed chronic‐phase chronic myeloid leukemia

Early results of lower dose dasatinib (50 mg daily) as frontline therapy for newly diagnosed chronic‐phase chronic myeloid leukemia

Generic formulations of imatinib for treatment of Philadelphia chromosome–positive leukemia in pediatric patients

Chronic myeloid leukemia: 2018 update on diagnosis, therapy and monitoring

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