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REVIEW
Fadi G Haddad, Hagop Kantarjian
Over the past several years, advances in research, treatment, and market dynamics have impacted treatment strategies in chronic myeloid leukemia in chronic phase (CML-CP). They include the broader availability of cost-effective generic imatinib, and soon other generic second-generation tyrosine kinase inhibitors (TKIs). Access to affordable generics means that all patients with CML-CP should have access to safe and highly effective lifelong therapies. When overall survival is the treatment endpoint, imatinib provides a good treatment value...
February 2024: Journal of the National Comprehensive Cancer Network: JNCCN
#2
JOURNAL ARTICLE
Stacie B Dusetzina
No abstract text is available yet for this article.
November 20, 2023: JAMA Internal Medicine
#3
REVIEW
Hagop M Kantarjian, Mary Alma Welch, Elias Jabbour
After two decades of use in chronic myeloid leukaemia, the risks and benefits of established treatment practices for BCR::ABL1 tyrosine kinase inhibitors (TKIs) in the chronic myeloid leukaemia in chronic phase of the disease should be analysed. In this Viewpoint, we suggest that the use of lower than approved TKI doses in both front-line and later-line therapies would result in similar treatment efficacy, less toxicity, better treatment compliance, and reduced cost of care. The absence of an early molecular response might not warrant a change of a TKI, particularly for second-generation TKIs...
October 2023: Lancet Haematology
#4
JOURNAL ARTICLE
Xiaoling Chen, Junmin Zhang, Quanyi Zhao, Li Ding, Zhengrong Wu, Zhong Jia, Dian He
With the continuous development of the pharmaceutical industry, people have always paid attention to the safety and effectiveness of drugs, including innovative drugs and generic drugs. For pharmaceutical companies as manufacturers, drug development is a very lengthy process that requires high costs, millions of man-hours, thousands of trials, and the mobilization of hundreds of researchers. Therefore, efforts need to be made to develop drugs with high safety and effectiveness. Drug research and development plays an important role today...
2023: Open Life Sciences
#5
JOURNAL ARTICLE
Mario Tiribelli, Roberto Latagliata, Massimo Breccia, Isabella Capodanno, Maria Cristina Miggiano, Francesco Cavazzini, Cristina Bucelli, Immacolata Attolico, Sabrina Leonetti Crescenzi, Sabina Russo, Mario Annunziata, Federica Sorà, Massimiliano Bonifacio, Olga Mulas, Giuseppina Loglisci, Alessandro Maggi, Gianni Binotto, Elena Crisà, Anna Rita Scortechini, Anna Paola Leporace, Rosaria Sancetta, Pamela Murgano, Elisabetta Abruzzese, Fabio Stagno, Davide Rapezzi, Debora Luzi, Iolanda Vincelli, Monica Bocchia, Carmen Fava, Alessandra Malato, Monica Crugnola, Michele Pizzuti, Francesca Lunghi, Sara Galimberti, Matteo Dalmazzo, Renato Fanin, Emilia Scalzulli, Robin Foà, Alessandra Iurlo, Giuseppe Saglio, Giorgina Specchia
BACKGROUND: Imatinib, dasatinib, and nilotinib are tyrosine kinase inhibitors (TKIs) approved in Italy for frontline treatment of chronic-phase chronic myeloid leukemia (CP-CML). The choice of TKI is based on a combined evaluation of the patient's and the disease characteristics. The aim of this study was to analyze the use of frontline TKI therapy in an unselected cohort of Italian patients with CP-CML to correlate the choice with the patient's features. METHODS: A total of 1967 patients with CP-CML diagnosed between 2012 and 2019 at 36 centers throughout Italy were retrospectively evaluated; 1089 patients (55...
June 24, 2023: Cancer
#6
JOURNAL ARTICLE
Brian D Cortese, Stacie B Dusetzina, Amy N Luckenbaugh, Bashir Al Hussein Al Awamlh, C J Stimson, Daniel A Barocas, David F Penson, Sam S Chang, Ruchika Talwar
PURPOSE: Self-administered oncology drugs contribute disproportionately to Medicare Part D spending; prices often remain high even after generic entry. Outlets for low-cost drugs such as Mark Cuban Cost Plus Drug Company (MCCPDC) offer opportunities for decreased Medicare, Part D, and beneficiary spending. We estimate potential savings if Part D plans obtained prices such as those offered under the MCCPDC for seven generic oncology drugs. METHODS: Using the 2020 Medicare Part D Spending dashboard, Q3-2022 Part D formulary prices, and Q3-2022 MCCPDC prices for seven self-administered generic oncology drugs, we estimated Medicare savings by replacing Q3-2022 Part D unit costs with costs under the MCCPDC plan...
June 8, 2023: Journal of Clinical Oncology
#7
REVIEW
Jessica Mounessa, Joseph V Caravaglio, Renee Domozych, Stephanie Chapman, Robert P Dellavalle, Cory A Dunnick, David Norris
BACKGROUND: The diagnosis and treatment of medication-associated alopecia often challenges patients and physicians. While numerous studies on the topic exist, limited information on the strength and magnitude of these studies exists. OBJECTIVES: We investigated the most commonly prescribed medications with high levels of evidence to support associations with alopecia. METHODS: A list of most commonly prescribed medications was compiled using the "Top 100 Prescriptions, Sales" (Intercontinental Marketing Services) and "Top 200 Names Searched" (RxList...
June 2023: Journal of the American Academy of Dermatology
#8
JOURNAL ARTICLE
Fangjun Chen, Wenda Chen, Zhenxin Wang, Yingfei Peng, Beili Wang, Baishen Pan, Wei Guo
INTRODUCTION: Tyrosine kinase inhibitors (TKIs) are widely used in tumor treatment. The detection of these medicines by liquid chromatography-tandem mass spectrometry (LC-MS/MS) can avoid the interference of structurally similar compounds. OBJECTIVES: This study aimed to develop and validate a new LC-MS/MS assay for the quantification of eight tyrosine kinase inhibitors in human plasma and to preliminarily evaluate the clinical utility of the therapeutic drug monitoring method...
August 2023: Journal of mass spectrometry and advances in the clinical lab
#9
JOURNAL ARTICLE
Deepak Goni, Arihant Jain, Charanpreet Singh, Nishant Jindal, Ram Nampoothiri, Aditya Jandial, Deepesh Lad, Alka Khadwal, Gaurav Prakash, Shano Naseem, Neelam Varma, Pankaj Malhotra
BACKGROUND & OBJECTIVES: Both innovator and generic imatinib are approved for the treatment of Chronic Myeloid Leukaemia-Chronic phase (CML-CP). Currently, there are no studies on the feasibility of treatment-free remission (TFR) with generic imatinib. This study attempted to determine the feasibility and efficacy of TFR in patients on generic Imatinib. METHODS: In this single-centre prospective Generic Imatinib-Free Trial-in-CML-CP study, twenty six patients on generic imatinib for ≥3 yr and in sustained deep molecular response (BCR ABLIS ≤0...
January 2023: Indian Journal of Medical Research
#10
JOURNAL ARTICLE
Deepak Goni, Arihant Jain, Charanpreet Singh, Nishant Jindal, Ram Nampoothiri, Aditya Jandial, Deepesh Lad, Alka Khadwal, Gaurav Prakash, Shano Naseem, Neelam Varma, Pankaj Malhotra
BACKGROUND & OBJECTIVES: Both innovator and generic imatinib are approved for the treatment of Chronic Myeloid Leukaemia-Chronic phase (CML-CP). Currently, there are no studies on the feasibility of treatment-free remission (TFR) with generic imatinib. This study attempted to determine the feasibility and efficacy of TFR in patients on generic Imatinib. METHODS: In this single-centre prospective Generic Imatinib-Free Trial-in-CML-CP study, twenty six patients on generic imatinib for ≥3 yr and in sustained deep molecular response (BCR ABLIS ≤0...
February 27, 2023: Indian Journal of Medical Research
#11
JOURNAL ARTICLE
Kristina Jenei, Mark P Lythgoe, Vinay Prasad
No abstract text is available yet for this article.
September 2022: Lancet Reg Health Am
#12
JOURNAL ARTICLE
Rayaz Ahmed, Reema Singh, Jyotsna Kapoor, Pritish Chandra Patra, Narendra Agrawal, Dinesh Bhurani, Rohan Halder
BACKGROUND: BCR-ABL Tyrosine kinase inhibitors (TKI's) are most successful of targeted therapies and are currently considered the cornerstone in the management of patients with chronic myeloid leukemia (CML). A recent study reported excellent outcomes of Dasatinib 50mg with better sustained response. Therefore, we aim to evaluate the molecular responses and safety of upfront Dasatinib 50mg in Indian CML-Chronic Phase patients. METHODS: It was an observational single-centre study...
November 21, 2022: Clinical Lymphoma, Myeloma & Leukemia
#13
Rumjhum Agrawal, Joao Vieira, Jacqueline Ryan, Harish Negi, Tanvi Rajput, Regina Corbin, Ricardo Viana
BACKGROUND AND OBJECTIVES: The management of chronic myeloid leukemia is associated with an extensive economic burden, and as novel interventions are being tested in this disease, understanding the comparative effectiveness is of interest. Findings and conclusions of this important issue continue to evolve with improvements in clinical research and economic understanding. This systematic literature review aims to conduct a comprehensive assessment of economic evaluations in chronic phase chronic myeloid leukemia...
December 2022: PharmacoEconomics
#14
REVIEW
Hagop Kantarjian, Shilpa Paul, Jigar Thakkar, Elias Jabbour
Several research and market developments in the past 5 years could influence front-line and subsequent-line strategies in chronic myeloid leukaemia. These developments include the increased availability of effective and safe generic imatinib at affordable prices, studies showing that doses of tyrosine kinase inhibitors (TKIs) lower than the approved dose are effective and less toxic, studies showing that dose-adjusted ponatinib therapy at a reduced dose is effective and substantially safer than approved doses, and the approval of asciminib as third-line therapy in 2021...
November 2022: Lancet Haematology
#15
RANDOMIZED CONTROLLED TRIAL
Meng Wang, Yifang Zhu, Ming Huang, Hao Wang, Wenjia Zhou, Dan Lu, Quanying Zhang
Nilotinib, a second-generation tyrosine kinase inhibitor (TKI), has been approved in the United States and Europe as a treatment for patients with newly diagnosed chronic myeloid leukemia (CML)-chronic phase (CP) and patients with CML-CP or chronic myeloid leukemia-accelerated phase (CML-AP) who are resistant or intolerant to imatinib (a first-generation TKI). This study compared the bioequivalence and safety of the test nilotinib capsule and reference nilotinib capsule (Tasigna, Novartis) in healthy Chinese volunteers under fasting conditions for marketing authorization in China...
October 2022: Clinical Pharmacology in Drug Development
#16
JOURNAL ARTICLE
Wenjuan Yu, Xin Du, Weiguang Wang, Jin Lou, Peng Liu, Li Meng, Jie Jin
BACKGROUND: Brand-name dasatinib was approved for newly diagnosed chronic myeloid leukemia-chronic phase (CML-CP) patients due to its deeper and faster molecular response than imatinib. Generics, as the alternative, low-cost forms, are much in demand. This study aimed to evaluate the efficacy and safety of generic dasatinib (Yinishu) as a first-line treatment in CML-CP. MATERIALS AND METHODS: This was a prospective, multicenter, single-arm study from May 2016 to October 2018 with a 2-year follow-up analysis...
May 21, 2022: Clinical Lymphoma, Myeloma & Leukemia
#17
JOURNAL ARTICLE
Yuk Man Cheung, Ho Wan Ip, Yok Lam Kwong
BACKGROUND: Imatinib and second-generation tyrosine-kinase inhibitors (2G-TKIs) are standard options for the first-line treatment of chronic myeloid leukaemia. Although 2G-TKIs are superior to imatinib in terms of rate and depth of molecular response, they do not bring significant improvements in survival outcomes, and concerns exist over their long-term safety. The availability of a generic formulation makes imatinib an attractive economical option. We propose a novel induction-maintenance approach that would have the advantage of inducing early molecular response with 2G-TKIs, followed by maintenance with the safer and more affordable imatinib...
July 2022: Lancet Oncology
#18
JOURNAL ARTICLE
Aoife Hollywood, John F Bourke
BACKGROUND: Imatinib mesylate is a first-generation tyrosine kinase inhibitor. Piperamido Nitrotoluene, also known as F5, is an intermediate used in the manufacturing of imatinib. We present a case series of allergic contact dermatitis to F5 in pharmaceutical workers. METHODS: Four male pharmaceutical workers were referred between 2007 and 2021 with new dermatitis predominantly affecting the periorbital region. All were involved in the production of imatinib and particularly exposed to F5...
July 15, 2022: Contact Dermatitis
#19
JOURNAL ARTICLE
Bryan S Walsh, Aaron S Kesselheim, Ameet Sarpatwari, Benjamin N Rome
PURPOSE: Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS: In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020...
April 1, 2022: Journal of Clinical Oncology
#20
REVIEW
R Ciftciler, I C Haznedaroglu
Philadelphia (Ph*)/BCR-ABL1-positive chronic myeloid leukemia (CML) is a neoplastic hematologic disorder, which is a functionally curable chronic disease via using tyrosine kinase inhibitor (TKI) drugs. The life expectancy for the vast majority of chronic phase-CML patients is "normal", thanks to the unique effectiveness of the ABL-targeted TKIs of CML. The patients with CML receiving TKI could be expected to have a survival and 'quality of life' of the age- and sex-matched healthy people. Several TKI pathways may be selected for the first line CML treatment, including first-generation original/generic imatinib or second-generation TKIs, such as bosutinib, nilotinib, and dasatinib...
December 2021: European Review for Medical and Pharmacological Sciences
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