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Generic imatinib

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
Larry Gorkin, Hagop Kantarjian
No abstract text is available yet for this article.
May 2016: Nature Reviews. Clinical Oncology
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
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
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
Rachna Arora, Manju Sharma, Tausif Monif, Sunil Iyer
PURPOSE: This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor's test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of investigational medicinal products (IMPs)...
July 2016: Cancer Research and Treatment: Official Journal of Korean Cancer Association
Fabio Stagno, Stefania Stella, Antonio Spitaleri, Maria Stella Pennisi, Francesco Di Raimondo, Paolo Vigneri
The tyrosine kinase inhibitor Imatinib Mesylate has dramatically improved the clinical outcome of chronic myeloid leukemia (CML) patients in the chronic phase of the disease, generating unprecedented rates of complete hematologic and cytogenetic responses and sustained reductions in BCR-ABL transcripts. Here, we present an overview on the efficacy and safety of Imatinib and describe the most important clinical studies employing this drug for the frontline treatment of chronic phase CML. We also discuss recent reports describing the long-term outcome of patients receiving Imatinib for their disease...
2016: Expert Review of Anticancer Therapy
Jean McDougall, Scott D Ramsey, Jerald Radich
No abstract text is available yet for this article.
February 2016: Journal of the National Comprehensive Cancer Network: JNCCN
Lisa M Bloudek, Dinara Makenbaeva, Michael Eaddy
BACKGROUND: Imatinib was the first BCR-ABL tyrosine kinase inhibitor (TKI) approved in the United States for the treatment of patients with chronic myelogenous leukemia and is currently the most prescribed TKI. The impending loss of patent exclusivity for imatinib has the potential to reduce costs for payers. OBJECTIVE: The primary objectives of this study were to estimate the economic impact of the loss of patent exclusivity for branded imatinib and to calculate the relative impact of requiring prior authorization (PA) for the use of generic imatinib before a branded TKI...
December 2015: American Health & Drug Benefits
Andrew Hill, Dzintars Gotham, Joseph Fortunak, Jonathan Meldrum, Isabelle Erbacher, Manuel Martin, Haitham Shoman, Jacob Levi, William G Powderly, Mark Bower
OBJECTIVE: To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). BACKGROUND: TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production...
2016: BMJ Open
Mehmet S Uyanik, Gulsum E Pamuk, Muhammet Maden, Elif Merev, Gokcen Cevik, Vesile Uyanik, Elif G Umit, Ahmet M Demir, Mustafa Akker
Treatment with tyrosine kinase inhibitors (TKIs) has dramatically changed the life expectancy of chronic myeloid leukaemia (CML) patients. Although the impact of first-generation TKIs on quality of life (QoL) was shown in CML, the effects of new generic formulations of imatinib mesylate (IM) are unclear. We evaluated differences in QoL under treatment with first- or second-generation TKIs. Fifty-two patients diagnosed with CP-CML completed the European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30, Hospital Anxiety and Depression Scale, and General Health Questionnaire...
November 23, 2015: European Journal of Cancer Care
Qian Jiang, Donglu Zhao, Jie Jin, Depei Wu, Fanyi Meng, Jianda Hu, Bingcheng Liu, Xin DU, Ting Liu, Yan Li, Ming Hou, Xiaopin Han, Zhixiang Shen, Jun Ma
OBJECTIVE: To evaluate the early hematologic, cytogenetic and molecular responses in newly diagnosed patients with chronic myelogenous leukemia in chronic phase(CML-CP)and initially treated with a generic imatinib(Xinwei), manufactured by Jiansu Hansoh Pharmaceutical Group Co., Ltd. METHODS: 107 newly diagnosed patients of CML-CP, whose ages were above 18- year- old and who had never received any tyrosine kinase inhibitor(TKI)were treated with Xinwei 400 mg QD...
August 2015: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
Musa Yilmaz, Yasmin Abaza, Elias Jabbour
With the discovery of Philadelphia chromosome, understanding of chronic myeloid leukemia (CML) pathobiology has tremendously increased. Development of tyrosine kinase inhibitors (TKI) targeting the BCR/ABL1 oncoprotein has changed the landscape of the disease. Today, the expected survival of CML patients, if properly managed, is likely to be similar to the general population. Imatinib is the first-approved TKI in CML treatment, and for several years, it was the only option in the frontline setting. Four years ago, second-generation TKIs (nilotinib and dasatinib) were approved as alternative frontline options...
June 2015: Current Hematologic Malignancy Reports
Juan Chen, Li Zhou, Shenghong Du, Hongying Lu, Shujun Sun, Junmin Li, Weili Zhao, Zhixiang Shen
No abstract text is available yet for this article.
March 2015: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
Rena M Conti, William V Padula, Richard A Larson
Imatinib is an oral tyrosine kinase inhibitor and considered to be the most successful targeted anti-cancer agent yet developed given its substantial efficacy in treating chronic myeloid leukemia (CML) and other malignant diseases. In the USA and the European Union (EU), Novartis' composition of matter patent on imatinib will expire in 2016. The potential impact on health system spending levels for CML after generic imatinib becomes available is the subject of significant interest among stakeholders. The extent of the potential savings largely depends on whether and to what extent prices decline and use stays the same or even increases...
April 2015: Annals of Hematology
Masako Yokoo, Yasushi Kubota, Yoko Tabe, Shinya Kimura
Long-term treatment with imatinib mesylate (IM) allows patients with chronic myeloid leukemia (CML) to live a near-normal lifespan. However, the fact that tyrosine kinase inhibitors, including IM, are extremely expensive is a major cause of poor adherence, resulting in disease relapse or drug resistance. Therefore, physicians are encouraged to prescribe generic drugs to reduce the financial burden of medical expenses. In Japan, only generic drugs that have a basic chemical structure and pharmacokinetic data that are the same as those of the original drug are approved...
2015: Biological & Pharmaceutical Bulletin
Ahmet Emre Eskazan, Teoman Soysal
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 health-care 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...
April 2016: Journal of Oncology Pharmacy Practice
Chetasi Talati, Evelena P Ontiveros, Elizabeth A Griffiths, Eunice S Wang, Meir Wetzler
Imatinib will become generic in 2016; assuming that its price will decrease precipitously, we expect that the economic forces will change our current practice habits. We reviewed the literature on the current recommendations to treat chronic myeloid leukemia and highlight how we plan to deal with these changes. Specifically, we propose to better characterize patients according to prognostic scores, to allow more attention to those at high risk for disease progression, e.g., 3-month guidelines and BCR/ABL1 message half-time, emphasize compliance by using contemporary technologies, and increase the importance of early monitoring...
March 2015: Blood Reviews
Melea A Ward, Gang Fang, Kristy L Richards, Christine M Walko, Stephanie R Earnshaw, Laura E Happe, Susan J Blalock
BACKGROUND: Chronic myeloid leukemia (CML) treatment guidelines recommend first-line therapy with either first- or second-generation tyrosine kinase inhibitors (1GTKI, 2GTKI), but do not specify which generation should be used first. OBJECTIVE: To examine the association between initiation of 2GTKI versus 1GTKI and medication adherence, health services utilization, and healthcare costs. METHOD: This was a retrospective cohort study utilizing administrative claims data from a single health plan within the US of commercial and Medicare patients newly initiating 1GTKI or 2GTKI therapy for CML between June 2010 and December 2011...
February 2015: Current Medical Research and Opinion
Velu Nair, Ajay Sharma, Jyoti Kotwal, M Bhikshapathy, D K Mishra, Satyaranjan Das, Sanjeevan Sharma, Rajan Kapoor, Jasjit Singh, Vivek Nair, Y Uday, Atul Kotwal
BACKGROUND: The BCR-ABL tyrosine kinase is a well validated therapeutic target in Chronic Myeloid Leukemia (CML). Imatinib mesylate (IM), a tyrosine kinase inhibitor is highly effective in the treatment of chronic phase CML. BCR - ABL transcripts have been well established as a molecular marker to document response to therapy in CML. Periodic monitoring of this marker helps in evolving therapeutic strategies with IM and also in diagnosing early relapse. This study was undertaken to monitor therapeutic response to IM in CML in chronic phase (CML-CP) by assessing BCR-ABL by real time quantitative PCR (RQ-PCR) techniques and to determine the effectiveness of the Indian generic IM...
October 2014: Medical Journal, Armed Forces India
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