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Generic imatinib

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https://www.readbyqxmd.com/read/29181139/outcome-of-frontline-treatment-with-generic-imatinib-in-adult-patients-with-chronic-myeloid-leukemia-in-algerian-population-a-multicenter-study
#1
B Entasoltan, M A Bekadja, H Touhami, N Mehalhal, Z Zouaoui, N Mesli, M Talbi, A Bachiri, M Michallet
Introduction: In a developing country like Algeria, such expensive therapy is not available. Alternative approaches are needed to help these adult. In Algeria 'imatib' (CIPLA-India) was introduced in 2006; but no study has been published yet in the North Africa region regarding response and outcome of this copy in CML patients. The goal of this multicenter study is to characterize newly adult CML in the western region of Algeria and to assess the effectiveness and safety of imatib (IM, copy) as frontline therapy for patients with CML...
2017: Mediterranean Journal of Hematology and Infectious Diseases
https://www.readbyqxmd.com/read/28949401/kronisk-myeloisk-leukemi-f%C3%A3-rebild-f%C3%A3-r-m%C3%A3-lstyrd-terapi-revolutionerande-%C3%A3-verlevnadsvinster-med-definitiv-bot-i-sikte-och-kraftigt-f%C3%A3-rb%C3%A3-ttrad-h%C3%A3-lsoekonomi
#2
Johan Richter, Leif Stenke
Chronic myeloid leukemia - a model disease for targeted therapy Chronic myeloid leukemia (CML) pioneered as the first human malignancy linked to a specific cytogenetic aberration (the Philadelphia chromosome), which led the way to specific targeted therapies with imatinib (Glivec) and later tyrosine kinase inhibitors (TKI). Continuous TKI administration, blocking the oncogenic fusion protein Bcr-Abl, has revolutionized the outcome of CML, transforming an almost uniformly deadly disease into a chronic disorder with a near to normal life expectancy for many patients...
September 21, 2017: Läkartidningen
https://www.readbyqxmd.com/read/28894944/higher-out-of-pocket-expenses-for-tyrosine-kinase-inhibitor-therapy-is-associated-with-worse-health-related-quality-of-life-in-persons-with-chronic-myeloid-leukemia
#3
Qian Jiang, Haibo Wang, Lu Yu, Robert Peter Gale
PURPOSE: To explore health-related quality-of-life (HRQoL) profiles and identify socio-demographic and clinical variables associated with HRQoL in persons with chronic myeloid leukemia (CML) receiving tyrosine kinase inhibitors (TKIs). METHODS: A cross-sectional questionnaire was distributed to adults with chronic-phase CML receiving tyrosine kinase-inhibitor (TKI) therapy >3 months in complete cytogenetic response (CCyR). Respondents were anonymous. SF-36 Health Survey was used to measure HRQoL...
December 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28844599/generic-imatinib-therapy-among-jordanians-an-observational-assessment-of-efficacy-and-safety-in-routine-clinical-practice
#4
Abdalla Awidi, Salah Abbasi, Kamal Alrabi, Khalid A Kheirallah
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...
August 5, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28810322/-comparison-of-generic-and-original-imatinib-in-the-treatment-of-newly-diagnosed-patients-with-chronic-myelogenous-leukemia-in-chronic-phase-a-multicenter-retrospective-clinical-study
#5
H Jiang, L T Zhi, M Hou, J X Wang, D P Wu, X J Huang
Objective: To evaluate the efficacy and safety of generic imatinib (Genike, Chiatai Tianqing Pharmaceutical Group Co., Ltd.) and imatinib (Glevic, Novartis, Switzerland) in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) . Methods: A retrospective study of 323 CML-CP patients (205 in Glivec treatment group and 118 in Genike group) who were ≥ 18 years old receiving imatinib monotherapy over the period of June 2013 to March 2016 was done to compare the differences of cytogenetics, molecular curative effect, survival, and adverse reactions between the two groups...
July 14, 2017: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/28742419/insights-into-the-management-of-chronic-myeloid-leukemia-in-resource-poor-settings-a-mexican-perspective
#6
REVIEW
Andrés Gomez-de-León, David Gómez-Almaguer, Guillermo J Ruiz-Delgado, Guillermo J Ruiz-Arguelles
The arrival of targeted therapy for chronic myeloid leukemia (CML) was revolutionary. However, due to the high cost of tyrosine kinase inhibitors, access to this highly effective therapy with strict monitoring strategies is limited in low to middle-income countries. In this context, following standard recommendations proposed by experts in developed countries is difficult. Areas covered: This review aims to provide an insight into the management of patients with CML living in a resource-limited setting. It addresses several issues: diagnosis, initial treatment, disease monitoring, and additional treatment alternatives including allogeneic hematopoietic stem cell transplantation...
September 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28717743/chronic-myeloid-leukemia-in-india
#7
REVIEW
Prasanth Ganesan, Lalit Kumar
BACKGROUND: In the last decade, the use of imatinib has brought a paradigm shift in the management of chronic myeloid leukemia (CML). In India, imatinib has been available for more than a decade and has been made accessible to all segments of the population because of patient assistance programs and cheaper generic versions. Despite improvements in survival, there are unique challenges in the Indian context. METHODS: We reviewed published data pertaining to CML in India for the period of 1990 to 2016, using PubMed advanced search with the terms chronic myeloid leukemia and India, and included studies that reported on epidemiology, monitoring for therapy, treatment outcomes, and resistance...
February 2017: Journal of Global Oncology
https://www.readbyqxmd.com/read/28643670/-chronic-myelogenous-leukemia-monitoring-and-predictors-of-a-favorable-response-to-treatment-with-imatinib
#8
María J Mela Osorio, Isabel A Giere, Isolda Fernández, Miguel A Pavlovsky, Dante Intile, Carolina Pavlovsky
The expected five-year survival of chronic-phase chronic myeloid leukemia patients treated with tyrosine kinase inhibitors is over 90%. Little data is available regarding the results in the Argentinian population. This information might be of interest as generic imatinib is now available in the region. The aim of this study is to provide information on monitoring and the long-term treatment with imatinib outside of a controlled clinical trial, as well as to analyze the predictive effect of early responses to achieve molecular remission 4...
2017: Medicina
https://www.readbyqxmd.com/read/28559151/generic-imatinib-in-chronic-myeloid-leukemia-survival-of-the-cheapest
#9
Madhav Danthala, Sadashivudu Gundeti, Siva Prasad Kuruva, Krishna Chaitanya Puligundla, Praveen Adusumilli, Ashok Pillai Karnam, Stalin Bala, Meher Lakshmi Konatam, Lakshmi Srinivas Maddali, Raghunadha Rao Digumarti
INTRODUCTION: The patent expiration of imatinib mesylate (Gleevec; Novartis) on February 1, 2016, has brought the focus back on generic versions of the drug, and an opportunity to provide a safe and cost-effective alternative. The objective of our study was to determine the molecular and cytogenetic responses, survival endpoints (event-free survival, failure-free survival, transformation-free survival, overall survival), and safety of innovator and generic brands of imatinib. MATERIALS AND METHODS: In this retrospective analysis, data from 1812 patients with chronic myeloid leukemia treated with frontline imatinib mesylate (innovator/generic) at a single institution between 2008 and 2014 is included...
May 10, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28445102/journey-of-generic-imatinib-a-case-study-in-oncology-drug-pricing
#10
Christopher T Chen, Aaron S Kesselheim
No abstract text is available yet for this article.
June 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28287008/the-value-of-open-access-and-a-patient-centric-approach-to-oral-oncolytic-utilization-in-the-treatment-of-chronic-myelogenous-leukemia-a-u-s-perspective
#11
REVIEW
Lopamudra Das, Matthew Gitlin, Lisa R Siegartel, Dinara Makenbaeva
Since the introduction of tyrosine kinase inhibitors (TKIs), the treatment of patients with chronic myelogenous leukemia (CML) has resulted in significant improvement in patient survival but at a higher pharmaceutical cost to payers. The recent introduction of generic imatinib presents an opportunity to lower pharmacy costs within a population that is growing due to improved survival. Recent literature has focused on the likely benefits to payers of step therapy through generic imatinib. Areas covered: This review provides a perspective that is broader than the evaluation of financial savings or narrowly defined health economic metrics by incorporating factors such as CML patient heterogeneity, including varying levels of disease progression risk, comorbidities and genetic mutation status, differences in TKI product profiles, clinical guideline recommendations, and the importance of individualized patient care...
April 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28283298/the-efficacy-of-generic-imatinib-as-first-and-second-line-therapy-3-year-follow-up-of-patients-with-chronic-myeloid-leukemia
#12
MULTICENTER STUDY
Erna Islamagic, Azra Hasic, Sabira Kurtovic, Emina Suljovic Hadzimesic, Lejla Mehinovic, Mirza Kozaric, Amina Kurtovic-Kozaric
INTRODUCTION: Generics of imatinib mesylate, the first tyrosine kinase inhibitor targeting the BCR-ABL1 fusion protein, have recently been approved in many countries as the alternative, low-cost forms for the treatment of patients with chronic myeloid leukemia (CML). The aim of this study was to evaluate the long-term clinical outcomes of patients with CML receiving first-line and second-line generic imatinib in Bosnia and Herzegovina. PATIENTS AND METHODS: This was a multicenter retrospective cohort study of patients (n = 41) treated with generic imatinib in Bosnia between September 1, 2013 and August 5, 2016...
April 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/27995880/-pharmacokinetics-of-generic-dasatinib-in-the-management-of-chronic-myeloid-leukemia-in-the-choronie-phase
#13
J Kong, N Chen, H X Fu, T J Hang, M Song, H Jiang
Objective: To evaluate the pharmacokinetics and bioequivalence of generic dasatinib in patients with chronic myeloid leukemia in the choronie phase (CML-CP). Methods: Using randomized, parallel, overlapping, self-control designed study, a 100 mg dose of the reference or test tablet was given to 12 CML-CP patients who were resistant or intolerant to Imatinib and Nilotinib in a randomized two-way crossover design, and the plasma concentration of the medicine was assayed by HPLC-MS-MS. The main pharmacokinetic parameters and bioequivalence of the two formulations were evaluated...
November 14, 2016: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/27916045/-a-comparison-of-efficacy-and-safety-between-chinese-generic-imatinib-versus-branded-imatinib-in-patients-with-newly-diagnosed-chronic-myeloid-leukemia-in-the-chronic-phase-a-single-center-prospective-cohort-study
#14
COMPARATIVE STUDY
H X Shi, Y Z Qin, Y Y Lai, X J Huang, Q Jiang
Objective: To compare the efficacy and safety between Chinese generic imatinib (Xinwei(®), Jiansu Hansoh Pharmaceutical Group Co., Ltd.) versus branded imatinib (Glivec(®), Novartis) in patients with newly-diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Methods: Patients with newly diagnosed CML-CP were enrolled and assigned to receive either Xinwei or Glivec at an initial dose of 400 mg/d according to patients' financial capability. The efficacy and adverse effects were evaluated. Results: From January 2014 to September 2015, 145 eligible patients were assigned to Xinwei (n=89) or Glivec (n=56) group...
December 1, 2016: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
https://www.readbyqxmd.com/read/27819247/generic-oncology-drugs-are-they-all-safe
#15
REVIEW
Y Tony Yang, Sumimasa Nagai, Brian K Chen, Zaina P Qureshi, Akida A Lebby, Samuel Kessler, Peter Georgantopoulos, Dennis W Raisch, Oliver Sartor, Terhi Hermanson, Robert C Kane, William J Hrushesky, Joshua J Riente, LeAnn B Norris, Laura R Bobolts, James O Armitage, Charles L Bennett
Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel)...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27245313/comparison-of-branded-and-generic-imatinib-plasma-concentrations-in-patients-with-chronic-myelogenous-leukemia-unicentric-study
#16
Alen Ostojic, Dubravka Sertic, Pavle Roncevic, Zinaida Peric, Paula Granic, Nikolina Matic, Sandra Basic-Kinda, Ranka Serventi-Seiwerth, Ivo Radman, Renata Zadro, Damir Nemet
INTRODUCTION: For over a decade, imatinib has been the first-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). Doubts on the bioequivalence and bioavailability of emerging generic compounds have been expressed. Adequate imatinib plasma concentration ([IPC] ≥1000 μmol/L) is associated with a better chance of optimal treatment response in patients with CML. In this study, we compared the achieved IPCs between the branded compound and its 2 generic forms...
August 2016: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/27098218/targeted-therapy-generic-imatinib-impact-on-frontline-and-salvage-therapy-for-cml
#17
COMMENT
Larry Gorkin, Hagop Kantarjian
No abstract text is available yet for this article.
May 2016: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/27085530/molecular-monitoring-of-tyrosine-kinase-inhibitor-therapy-of-chronic-myeloid-leukemia-in-china
#18
Qian Jiang, Robert Peter Gale
PURPOSE: Explore molecular monitoring patterns of patients with chronic myeloid leukemia (CML) on tyrosine kinase inhibitors therapy in China and identify variables associated with monitoring patterns. METHODS: Non-interventional, cross-sectional study using questionnaires distributed to persons with CML and answered anonymously. RESULTS: A total of 819 respondents in chronic phase outside clinical trials were evaluable; 477 respondents (58 %) were male...
July 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/26944912/cost-effectiveness-of-tyrosine-kinase-inhibitor-treatment-strategies-for-chronic-myeloid-leukemia-in-chronic-phase-after-generic-entry-of-imatinib-in-the-united-states
#19
COMPARATIVE STUDY
William V Padula, Richard A Larson, Stacie B Dusetzina, Jane F Apperley, Rudiger Hehlmann, Michele Baccarani, Ekkehard Eigendorff, Joelle Guilhot, Francois Guilhot, Rudiger Hehlmann, Francois-Xavier Mahon, Giovanni Martinelli, Jiri Mayer, Martin C Müller, Dietger Niederwieser, Susanne Saussele, Charles A Schiffer, Richard T Silver, Bengt Simonsson, Rena M Conti
BACKGROUND: We analyzed the cost-effectiveness of treating incident chronic myeloid leukemia in chronic phase (CML-CP) with generic imatinib when it becomes available in United States in 2016. In the year following generic entry, imatinib's price is expected to drop 70% to 90%. We hypothesized that initiating treatment with generic imatinib in these patients and then switching to the other tyrosine-kinase inhibitors (TKIs), dasatinib or nilotinib, because of intolerance or lack of effectiveness ("imatinib-first") would be cost-effective compared with the current standard of care: "physicians' choice" of initiating treatment with any one of the three TKIs...
July 2016: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/26924275/is-sunitinib-a-narrow-therapeutic-index-drug-a-systematic-review-and-in%C3%A2-vitro-toxicology-analysis-of-sunitinib-vs-imatinib-in-cells-from-different-tissues
#20
REVIEW
Bodo Haas, Konstantin Weber-Lassalle, Roland Frötschl, Niels Eckstein
Narrow Therapeutic Index Drugs (NTIDs) are characterized by a small range between therapeutic and toxicological effect. Missing international harmonized definition for NTIDs the EMA does not even have a definition of NTIDs in contrast to the U.S. FDA, Health Canada, and the Japanese NIHS. Sunitinib, a tyrosine kinase inhibitor (TKI), indicated for the treatment of certain cancer types, will be running off-patent soon. Falling into the category of NTID would have a major impact on regulatory requirements for generic applications...
June 2016: Regulatory Toxicology and Pharmacology: RTP
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