Safety and efficacy of switching from branded to generic imatinib in chronic phase chronic myeloid leukemia patients treated in Italy (original) (raw)
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Generic Imatinib in the Treatment of Chronic Myeloid Leukemia: Two Years’ Experience in Latvia
Experimental Oncology, 2019
Background: Imatinib is tyrosine kinase inhibitor (TKI) and as a targeted anti-cancer agent has significantly changed chronic myeloid leukemia (CML) prognosis and patient survival. Currently TKI is the main therapy in CML Philadelphia chromosome-positive (Ph-positive) cases. When generics of imatinib appeared in the pharmaceuticals market, reimbursement policies in many countries switched to using generics or encouraged use of generic imatinib to lower the expenses. Cost savings were substantial; however, for doctors and CML patients the efficacy, safety and quality of generic imatinib were an issue of concern. Objective: Since the global number of CML patients, who in the future will have to switch from original imatinib to generic imatinib, is high, the aim of study was to monitor, whether during 24 months of generic imatinib usage patients maintain the achieved major molecular response (MMR) or whether the treatment results are inferior. Methods: We conducted a retrospective stud...
Introduction and Aim: Generic imatinib formulations are increasingly being used as more affordable alternatives worldwide and a few studies have evaluated the safety and efficacy of these. We have retrospectively analyzed our chronic-phase chronic myeloid leukemia (CP- CML) cohort in terms of first-line treatment with Glivec versus generic imatinib. This study aims to evaluate the safety and efficacy of generic imatinib products in CP- CML as the first-line treatment. Material and Method: We retrospectively analyzed our CP- CML cohort from January 2000 to December 2020 treated with either Glivec or one of the generic imatinib formulations. All our patients were followed in accordance with European Leukemia Net (ELN) 2020 recommendations and national hematology association CML guidelines and response definitions were applied according to ELN 2020 criteria. Event-free survival (EFS) was defined as the time between treatment initiation and either loss of hematological response, progres...
Vojnosanitetski pregled
Background / Aim. The treatment of chronic myeloid leukemia (CML) has changed dramatically with the advent of targeted therapies. The study aimed to assess the efficacy of generic imatinib in CML patients treated in our center. Methods The study was retrospective. It included 101 patients with the diagnosis of CMLchronic phase (CP). There were two study groups. Group 1 included 55 patients initially treated with branded imatinib and then switched to generic imatinib. Group 2 consisted of 46 newly diagnosed patients who received only generic imatinib from the start of therapy. Results. The patients were treated with branded imatinib for the mean of 42 months (range 6-132 months) before switching to generic imatinib. Treatment with generic imatinib lasted for 25 months in average (range 3-66 months). A quarter of the patients from Group 1 lost their cytogenetic response after being switched to generic imatinib but without signs of transformation to acute leukemia. Patients treated with branded imatinib had a significantly longer event-free survival (EFS) and failure-free survival (FFS) (log-rank p=0.01 and p=0.03). These results could have been influenced by frequent changes of the brand and dosage formulation of generic imatinib. Conclusions. Our study showed a significantly longer EFS nad FFS on treatment with initially branded imatinib due to cross over study design, but provide some informative data of these two group of patients Key words: branded imatinib mesylate; generic imatinib mesylate; chronic myeloid leukemia. Apstrakt Uvod / Cilj. Ciljna terapija je značajno izmenila uspeh lečenje bolesnika sa hroničnom mijeloidnom leukemijom. Cilj rada je bio da se proceni efikasnost lečenja obolelih od hronične mijeloidne leukemije generičkim imatinibom u našem centru. Metode: Istraživanje je bilo retrospektivno. Obuhvatilo je 101 obolelog od hronične mijeloidne leukemije u hroničnj fazi. Bolesnici su bili podeljeni u dve grupe. Prvu grupu je činilo 55 bolesnika koji su inicijalno lečenji originalnim imatinibom i koji su kasnije tokom lečenja prevedeni na terapiju gneričkim imatinibom. Drugu grupu je činilo 46 novodijagnostikovanih bolesnika koji su od početka lečeni generičkim imatinibom. Rezultati. Bolesnici su originalnim imatinibom lečeni u proseku 42 meseca (od 6 do 132 4 meseca) nakon čega su prevedeni na generički imatinib. Lečenje generičkim imatinibom je u proseku trajalo 25 meseci (od 3 do 66 meseci). Četvrtina bolesnika prve grupe je izgubila citogenetski odgovor nakon prevoĎenja na generički imatinib. Nije bilo znakova za transformaciju u akutnu leukemiju. Bolesnici lečeni originalnim imatinibom su imali statistički značajno duže preživljavanje bez dogaĎaja koje podrazumeva smrtni ishod i preživljavanje bez neuspeha terapije (log-rank p=0.01 and p=0.03). Na ovakve rezultate je mogla imati uticaj učestala promena dozne formulacije i poizvoĎača generičkog imatiniba. Zaključak. Naše istraživanje je ukazalo na značajno duže preživljavanje bez dogaĎaja koje podrazumeva smrtni ishod i preživljavanje bez neuspeha terapije kod bolesnika koji su lečenje započeli originalnim imatinibom u odnosu na drugu grupu pacijenata koji su lečeni sve vreme generičkim imatinibom. Navedeni rezultati pružaju korisnu informaciju, ali se moraju tumačiti u kontekstu studije po tipu "cross over dizajna". Ključne reči: brendirani imatinib mesilat; generički imatinib mesilat; hronična mijeloidna leukemija.
Generic imatinib in the treatment of chronic myeloid leukemia: Cerrahpa a experience
Journal of Oncology Pharmacy Practice, 2015
As the first tyrosine kinase inhibitor (TKI), imatinib (Gleevec or Glivec, Novartis Pharmaceuticals) was introduced, the treatment of chronic myeloid leukemia (CML) has changed radically, and the TKIs are now the mainstay of CML treatment. The substantially high treatment cost has unfortunately been a major issue, which puts a strain on healthcare budgets even in developed countries. So reimbursement policies encourage generic drug (i.e. generic imatinib) use to lower the expenses, and it is true that generics would lead to considerable cost savings, but they also give rise to questions associated with their efficacy, safety and quality. In this commentary, we discuss the current evidence on generic imatinib based mainly on our ''Cerrahpaşa'' experience along with other data available in the literature together with the data discussed by de Lemos and colleagues.
European Journal of Cancer, 2013
Background: Tyrosine kinase inhibitors treatment in responding chronic myeloid leukaemia (CML) patients is generally continued indefinitely. In this randomised phase II trial, we investigated whether CML patients in molecular response 4.5 (MR 4.5 , quantitative reverse-transcription polymerase chain reaction (RQ-PCR)) after previous combination therapy with imatinib and cytarabine may discontinue imatinib treatment safely. Patients and methods: Thirty-three patients from the HOVON 51 study with an MR 4.5 for at least 2 years who were still on imatinib treatment were randomised between continuation of imatinib (arm A, n = 18) or discontinuation of imatinib (arm B, n = 15). Results: After a median follow up of 36 months since randomisation, 3 patients (17%) in arm A and 10 patients (67%) in arm B had a molecular relapse. All 3 relapsing patients in arm A
Blood, 2020
Background: Data on the safety and efficacy of copy drugs is usually unavailable. Imatinib mesylate is used to treat chronic myeloid leukemia (CML) patients in Argentina since 2002. During the last decade more than ten different imatinib copies are marketed by the different health-care systems in the country, usually for cost issues. In spite of the undoubted benefit of this tyrosine-kinase inhibitor indication in CML, there is no solid evidence that supports copy drug equivalent outcomes for this patient population. Aim: To compare the clinical presentation, treatment response and outcome of a chronic phase (CP) CML patient cohort treated with branded and copy imatinib in the real-life setting. Methods: Multicentric, retrospective trial based on data obtained from medical charts of adult CP CML patients treated with imatinib in 9 centers in Argentina from 2002 to 2020.We analyzed demographic characteristics and clinical characteristics described for branded and copy imatinib treate...
Value in Health, 2011
To estimate the cost-effectiveness of dasatinib and nilotinib compared with high-dose imatinib for people with chronic phase chronic myeloid leukemia, which are resistant to normal-dose imatinib and compared with interferon-␣ for people intolerant to imatinib, from the perspective of the UK National Health Service. Methods: An an area under the curve partitioned survival model was developed to estimate the cost-effectiveness of dasatinib and nilotinib. Clinical effectiveness evidence was taken mostly from single-arm trials. Results: Both progression-free survival and overall survival are highly uncertain. In the base case, patients take nilotinib for much less time than dasatinib. Nilotinib is expected to dominate high-dose imatinib, yielding slightly more (0.32) quality-adjusted life years (QALYs) at slightly less cost (£11,100 [pound sterling]) per person. Dasatinib is predicted to provide slightly more (0.53) QALYs at substantially greater cost (£48,900), yielding a very high incremental cost-effectiveness ratio of £91,500 QALY against high-dose imatinib. Cost-effectiveness, however, changes radically under the plausible assumption that the drugs are taken for the same time. For people intolerant to imatinib, nilotinib is expected to yield an incremental cost-effectiveness ratio of £104,700/ QALY, and dasatinib £82,600/QALY compared with interferon-␣. Further, both drugs represent poor value for money for a range of plausible structural assumptions. Conclusions: The model should be viewed as an exploratory analysis of the cost-effectiveness of dasatinib and nilotinib because it relies on many assumptions. Whilst clinical data remains immature, the cost-effectiveness of dasatinib and nilotinib for imatinib-resistant people is highly uncertain. Both nilotinib and dasatinib are highly unlikely to be cost-effective versus interferon-␣ for people intolerant to imatinib.
Clinical Lymphoma Myeloma and Leukemia
This observational study was conducted to assess the efficacy and safety of generic imatinib in 91 patients with chronic myeloid leukemia (either treated first-line or switched from patented to generic imatinib). Efficacy and safety of generic imatinib was comparable with patented imatinib. These results support the use of generic imatinib to reduce health care expenditure per patient and increase patient access. Introduction: Generic imatinib therapy is being globally considered owing to cost considerations. However, evidence of its efficacy and safety in Middle Eastern clinical settings is scarce. Patients and Methods: The efficacy and safety of generic imatinib (Cemivil) were assessed among Jordanian patients diagnosed with chronic myeloid leukemia using an observational, multicenter, prospective study design. Responses were defined using European LeukemiaNet 2009 guidelines and assessed by complete blood counts, fluorescence in situ hybridization, and real-time quantitative polymerase chain reaction. Results: All patients (N ¼ 91) were adults with chronic myeloid leukemia treated with generic imatinib 400 mg/day. Thirty-three patients received generic imatinib as first-line therapy, and 58 switched from patented imatinib to generic imatinib after a median of 4.5 years (range, 0.5-13.6 years) of imatinib therapy. The majority (85%; n ¼ 28) of the first-line patients achieved complete hematologic response within 3 months of starting generic imatinib therapy (100% after 6 months [n ¼ 33]). The 12-month major molecular response rate in the intentionto-treat population was 45%. The 12-month major molecular response rate was 88% for patients who switched therapy. The 12-month progression-free and overall survival rates were 92% and 100%, respectively. Most (85%; n ¼ 144) adverse events were mild. Frequencies of drug-related adverse events were similar to patented imatinib. Conclusion: This study suggests that the efficacy and safety of generic imatinib in this Middle Eastern population in routine clinical practice are comparable to patented imatinib, and to that of the global population.