Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study

Gemelli, M; Elli, Elena Maria; Elena, Chiara; Iurlo, Alessandra; Intermesoli, Tamara; Maffioli, Margherita; Pungolino, Ester; Carraro, Maria Cristina; D’Adda, Mariella; Lunghi, Francesca; Anghileri, Michela; Polverelli, Nicola; Rossi, Marianna; Bacciocchi, Mattia; Bono, Elisa; Bucelli, Cristina; Passamonti, Francesco; Antolini, Laura; Gambacorti‐Passerini, Carlo

doi:10.5045/br.2020.2020130

Cited by 8 publications

(7 citation statements)

References 31 publications

(38 reference statements)

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“…On the other hand, a recently published study displayed significantly improved muscle cramps, edema, fatigue, and diarrhea after switching to generics. 25 Other studies demonstrated comparable results between the original molecule and generics regarding safety. 26,27 Generics after switching from frontline original imatinib.…”

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 81%

“…Sustained, improved, and worsened molecular response rates under generics were 69%, 25.5%, and 5.5%, respectively. 25 Interestingly, the rate of AEs at any grade was 54.5% under generic imatinib therapy, whereas this was 85% with branded imatinib. In addition, the rates of grade 3 to 4 toxicities under branded imatinib and generics were 8% and 3.5%, respectively.…”

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 98%

“…Six studies evaluated the efficacy of generics after switching from original imatinib, [20][21][22][23][24][25] whereas another 7 compared Gleevec with generics in the upfront setting. [26][27][28][29][30][31][32] Additionally, 4 studies reported the combination of both frontline and subsequent uses of generics.…”

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 99%

“…Fatigue, muscle cramps, myalgia, edema, diarrhea, and rash were significantly lower under generic imatinib, and only 3 patients switched back to branded imatinib because of intolerance. 25 There were 2 possible explanations for these findings: first, better tolerability resulting from long-term generic use and second, but more importantly, possible underestimation of AEs because of extraction of the toxicity data directly from the physicians but not from the patients.…”

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 99%

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Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs

Erçalışkan¹,

Erdoğan

Eşkazan³

2021

Blood Advances

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Since the introduction of imatinib, the management of chronic myeloid leukemia (CML) has changed considerably. Tyrosine kinase inhibitors (TKIs) are the mainstay of CML treatment; however, the high financial burden of TKIs can be problematic for both the patients and health care systems. After the emergence of generics, reimbursement policies of many countries have changed, and generics offered an alternative treatment option for CML patients. There are many papers published on the use of generics in CML patients with conflicting results regarding both efficacy and safety. In this paper, we systematically reviewed the current literature on generic imatinib use in CML, and 36 papers were evaluated. Both in vitro and in vivo studies of generic imatinib showed comparable results with branded imatinib in terms of bioequivalence and bioavailability. In most studies, generics were comparable with the original molecule in terms of efficacy and safety, both in newly diagnosed patients and after switching from Gleevec. Some generic studies showed contradictory findings regarding efficacy and toxicity, and these differences can be attributed to some factors including the use of different generics in different countries. Both in hypothetical models and in real life, introduction of generic imatinib caused significant reduction in health care costs. In conclusion, generics are not inferior to original imatinib in terms of efficacy with an acceptable toxicity profile. Notwithstanding the generally favorable efficacy and safety of generics worldwide to date, we most probably still need more time to draw firmer conclusions on the longer-term outcomes of generics.

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Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 81%

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 98%

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 99%

Section: Efficacy and Safety Of Generic Imatinibmentioning

confidence: 99%

See 2 more Smart Citations

Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs

Erçalışkan¹,

Erdoğan

Eşkazan³

2021

Blood Advances

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“…[92][93][94][95][96] The generic version of innovator drug (imatinib) has been shown to be noninferior to innovator drug (imatinib) in terms of efficacy with an acceptable toxicity profile. [97][98][99] A US FDA-approved generic version is an appropriate substitute for an innovator drug (imatinib). 100 Innovator and generic drugs approved by the regulatory authorities based on pharmacokinetic equivalence can be used interchangeably.…”

Section: Risk Stratificationmentioning

confidence: 99%

Chronic Myeloid Leukemia, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology

Shah,

Bhatia,

Altman

et al. 2024

Journal of the National Comprehensive Cancer Network

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Chronic myeloid leukemia (CML) is defined by the presence of Philadelphia chromosome resulting from a reciprocal translocation between chromosomes 9 and 22 [t9;22] that gives rise to a BCR::ABL1 fusion gene. CML occurs in 3 different phases (chronic, accelerated, and blast phase) and is usually diagnosed in the chronic phase in developed countries. Tyrosine kinase inhibitor (TKI) therapy is a highly effective treatment option for patients with chronic phase–CML. The primary goal of TKI therapy in patients with chronic phase–CML is to prevent disease progression to accelerated phase–CML or blast phase–CML. Discontinuation of TKI therapy with careful monitoring is feasible in selected patients. This manuscript discusses the recommendations outlined in the NCCN Guidelines for the diagnosis and management of patients with chronic phase–CML.

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Novel therapeutic agents in clinical trials: emerging approaches in cancer therapy

Joshi,

Sharma,

Prasad

et al. 2024

Discov Onc

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Novel therapeutic agents in clinical trials offer a paradigm shift in the approach to battling this prevalent and destructive disease, and the area of cancer therapy is on the precipice of a trans formative revolution. Despite the importance of tried-and-true cancer treatments like surgery, radiation, and chemotherapy, the disease continues to evolve and adapt, making new, more potent methods necessary. The field of cancer therapy is currently witnessing the emergence of a wide range of innovative approaches. Immunotherapy, including checkpoint inhibitors, CAR-T cell treatment, and cancer vaccines, utilizes the host’s immune system to selectively target and eradicate malignant cells while minimizing harm to normal tissue. The development of targeted medicines like kinase inhibitors and monoclonal antibodies has allowed for more targeted and less harmful approaches to treating cancer. With the help of genomics and molecular profiling, “precision medicine” customizes therapies to each patient’s unique genetic makeup to maximize therapeutic efficacy while minimizing unwanted side effects. Epigenetic therapies, metabolic interventions, radio-pharmaceuticals, and an increasing emphasis on combination therapy with synergistic effects further broaden the therapeutic landscape. Multiple-stage clinical trials are essential for determining the safety and efficacy of these novel drugs, allowing patients to gain access to novel treatments while also furthering scientific understanding. The future of cancer therapy is rife with promise, as the integration of artificial intelligence and big data has the potential to revolutionize early detection and prevention. Collaboration among researchers, and healthcare providers, and the active involvement of patients remain the bedrock of the ongoing battle against cancer. In conclusion, the dynamic and evolving landscape of cancer therapy provides hope for improved treatment outcomes, emphasizing a patient-centered, data-driven, and ethically grounded approach as we collectively strive towards a cancer-free world.

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Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study

Cited by 8 publications

References 31 publications

Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs

Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs

Chronic Myeloid Leukemia, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology

Novel therapeutic agents in clinical trials: emerging approaches in cancer therapy

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