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trastuzumab biosimilar

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https://www.readbyqxmd.com/read/29699853/monoclonal-antibody-biosimilars-in-oncology-critical-appraisal-of-available-data-on-switching
#1
Paul Declerck, Georgios Bakalos, Elias Zintzaras, Bettina Barton, Thomas Schreitmüller
PURPOSE: With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies...
April 23, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29580109/total-pathological-complete-response-versus-breast-pathological-complete-response-in-clinical-trials-of-reference-and-biosimilar-trastuzumab-in-the-neoadjuvant-treatment-of-breast-cancer
#2
Justin Stebbing, Yauheni Baranau, Alexey Manikhas, Sang Joon Lee, Paul Thiruchelvam, Daniel Leff, Francisco J Esteva
Trastuzumab is a key drug in the neoadjuvant treatment of breast cancers that overexpress the human epidermal growth factor receptor 2 (HER2). Pathological complete response (pCR) is commonly used as an endpoint in neoadjuvant clinical trials of trastuzumab as evidence suggests it may be a surrogate for long-term survival. Several biosimilar candidates of originator or 'reference' trastuzumab are in development and have used pCR as a primary endpoint to assess therapeutic equivalence between treatments. The exact definition of pCR has varied across studies...
March 27, 2018: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/29525430/the-global-need-for-a-trastuzumab-biosimilar-for-patients-with-her2-positive-breast-cancer
#3
REVIEW
Kimberly Blackwell, Joseph Gligorov, Ira Jacobs, Chris Twelves
Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+ ) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2+ metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2+ MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or any other HER2-targeted agent as first- and/or later-line for treatment of metastatic disease...
April 2018: Clinical Breast Cancer
https://www.readbyqxmd.com/read/29502805/a-randomized-phase-i-study-comparing-the-pharmacokinetics-of-hd201-a-trastuzumab-biosimilar-with-european-union-sourced-herceptin
#4
Xavier Pivot, Jean Paul Deslypere, Lisa Soyeon Park, Michael Jinwoo Kim, Wonjae Lee, Jeonghyeon Lee
PURPOSE: This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*. METHODS: In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC0-∞ . Equivalence was determined by using the predefined margins of 0...
March 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29482416/evaluation-of-analytical-similarity-between-trastuzumab-biosimilar-ct-p6-and-reference-product-using-statistical-analyses
#5
Jihun Lee, Hyun Ah Kang, Jin Soo Bae, Kyu Dae Kim, Kyoung Hoon Lee, Ki Jung Lim, Min Joo Choo, Shin Jae Chang
The evaluation of analytical similarity has been a challenging issue for the biosimilar industry because the number of lots for reference and biosimilar products available at the time of development are limited, whilst measurable quality attributes of target molecule are numerous, which can lead to potential bias or false negative/positive conclusions regarding biosimilarity. Therefore, appropriate statistical analyses are highly desirable to achieve a high level of confidence in the similarity evaluation. A recent guideline for the risk-based statistical approaches recommended by the US Food and Drug Administration provides useful tools to systematically evaluate analytical similarity of biosimilar products compared with reference products...
February 26, 2018: MAbs
https://www.readbyqxmd.com/read/29482364/efficacy-and-safety-of-the-trastuzumab-biosimilar-candidate-ct-p6
#6
Francisco J Esteva, Toshiaki Saeki, HoUng Kim, Justin Stebbing
Trastuzumab is an anti-HER2 monoclonal antibody indicated for the treatment of HER2-overexpressing breast and gastric cancers. Despite its clinical efficacy, access to the biological drug can be limited due to its relatively high price, especially in low-income countries. CT-P6 (Herzuma® ) is a biosimilar candidate of originator or 'reference' trastuzumab, which may offer an alternative, more cost-effective treatment option. This article reviews the unmet needs of patients eligible to receive reference trastuzumab and the potential place of a trastuzumab biosimilar within the market...
February 27, 2018: Future Oncology
https://www.readbyqxmd.com/read/29448072/a-phase-iii-study-comparing-sb3-a-proposed-trastuzumab-biosimilar-and-trastuzumab-reference-product-in-her2-positive-early-breast-cancer-treated-with-neoadjuvant-adjuvant-treatment-final-safety-immunogenicity-and-survival-results
#7
X Pivot, I Bondarenko, Z Nowecki, M Dvorkin, E Trishkina, J-H Ahn, S-A Im, T Sarosiek, S Chatterjee, M Z Wojtukiewicz, Y Shparyk, V Moiseyenko, M Bello, V Semiglazov, Y Lee, J Lim
BACKGROUND: The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer was demonstrated in the previous report. Here, we report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment. PATIENTS AND METHODS: Patients were randomised 1:1 to receive neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide)...
April 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29373094/phase-iii-randomized-double-blind-study-comparing-the-efficacy-safety-and-immunogenicity-of-sb3-trastuzumab-biosimilar-and-reference-trastuzumab-in-patients-treated-with-neoadjuvant-therapy-for-human-epidermal-growth-factor-receptor-2-positive-early-breast
#8
Xavier Pivot, Igor Bondarenko, Zbigniew Nowecki, Mikhail Dvorkin, Ekaterina Trishkina, Jin-Hee Ahn, Yuriy Vinnyk, Seock-Ah Im, Tomasz Sarosiek, Sanjoy Chatterjee, Marek Z Wojtukiewicz, Vladimir Moiseyenko, Yaroslav Shparyk, Maximino Bello, Vladimir Semiglazov, Sujeong Song, Jaeyun Lim
Purpose This phase III study compared SB3, a trastuzumab (TRZ) biosimilar, with reference TRZ in patients with human epidermal growth factor receptor 2-positive early breast cancer in the neoadjuvant setting ( ClinicalTrials.gov identifier: NCT02149524). Patients and Methods Patients were randomly assigned to receive neoadjuvant SB3 or TRZ for eight cycles concurrently with chemotherapy (four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide) followed by surgery, and then 10 cycles of adjuvant SB3 or TRZ...
April 1, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29350568/abp-980-promising-trastuzumab-biosimilar-for-her2-positive-breast-cancer
#9
Elisavet Paplomata, Rita Nahta
Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies. Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016-2017 ASCO and ESMO conference proceedings for 'ABP 980' or 'trastuzumab biosimilar'...
March 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29330636/a-randomised-trial-comparing-the-pharmacokinetics-and-safety-of-the-biosimilar-ct-p6-with-reference-trastuzumab
#10
Francisco J Esteva, Justin Stebbing, Rebecca N Wood-Horrall, Peter J Winkle, Sung Young Lee, Sang Joon Lee
PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin® ) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males...
March 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29273617/fda-approves-trastuzumab-biosimilar
#11
(no author information available yet)
On December 1, the FDA approved a second cancer biosimilar, trastuzumab-dkst. The drug was approved to treat patients with HER2-positive breast and metastatic stomach cancers.
February 2018: Cancer Discovery
https://www.readbyqxmd.com/read/29173192/the-ecstacy-of-gold-patent-expirations-for-trastuzumab-bevacizumab-rituximab-and-cetuximab
#12
Tasha R Serna-Gallegos, Christopher J LaFargue, Krishnansu S Tewari
BACKGROUND: Fully humanized monoclonal antibodies have revolutionized the treatment of many solid tumors, including breast, lung, colorectal, and ovarian cancer. Among the most widely used monoclonal antibodies in clinical oncology are cetuximab, trastuzumab, rituximab, and bevacizumab. OBJECTIVE: This article will review these four notable monoclonal antibodies, their role in clinical oncology, and the drug patents that are nearing expiration. RESULTS: They are used in both first and second line treatment regimens for multiple common malignancies...
November 22, 2017: Recent Patents on Biotechnology
https://www.readbyqxmd.com/read/29129095/trastuzumab-biosimilar-in-early-breast-cancer-setting-will-there-be-direct-patient-benefits
#13
EDITORIAL
Arlene Chan
No abstract text is available yet for this article.
October 2017: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/29094099/improving-access-to-cancer-treatments-the-role-of-biosimilars
#14
Rakesh Chopra, Gilberto Lopes
Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply. The cost of biologics limits accessibility of cancer treatment for many patients. Effective and affordable cancer therapies are needed globally, more so in developing countries, where health care resources can be limited. Biosimilars, which have biologic activity comparable to their corresponding reference drugs and are often more cost effective, have the potential to enhance treatment accessibility for patients and provide alternatives for decision makers (ie, prescribers, regulators, payers, policymakers, and drug developers)...
October 2017: Journal of Global Oncology
https://www.readbyqxmd.com/read/29076054/prevalence-of-use-and-cost-of-biological-and-non-biological-targeted-therapies-for-cancer-treatment-a-5-year-picture-from-southern-italy
#15
Simona Lucchesi, Ilaria Marcianò, Paolo Panagia, Rosanna Intelisano, Maria Pia Randazzo, Carmela Sgroi, Giuseppe Altavilla, Mariacarmela Santarpia, Vincenzo Adamo, Tindara Franchina, Francesco Ferraù, Paolina Reitano, Gianluca Trifirò
BACKGROUND AND OBJECTIVES: Considering the clinical and economic burden of biological and non-biological targeted therapies in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological and non-biological targeted therapies for cancer treatment in a general population of Southern Italy in the years 2010–2014...
March 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29061013/-the-development-of-biosimilars-in-oncology
#16
S Y Jiang, Y K Shi
With the extensive application in clinical practice, biological medicine plays a significant role in both treatment and supportive care in oncology. With the expiration of original drug patents, biosimilars emerge. The biosimilars are defined as biological drugs that are be highly similar but not identical to the biological reference. Their development and evaluation procedure are different from those of small molecular chemical generics. Biosimilars are expected to reduce the health care costs worldwide. The booming developments of biosimilars, such as rituximab, trastuzumab and bevacizumab in medical oncology can optimize the clinical strategies, offer patients more treatment options and reduce the medical expenditure...
October 23, 2017: Zhonghua Zhong Liu za Zhi [Chinese Journal of Oncology]
https://www.readbyqxmd.com/read/28898593/biosimilars-implications-for-clinical-practice
#17
Robert M Rifkin, Susan R Peck
In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#18
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28814565/trastuzumab-biosimilar-on-track-for-approval
#19
(no author information available yet)
An FDA expert panel recommended approval of Mylan's MYL-14010, a biosimilar candidate for Genentech's trastuzumab, putting it on track to become the first approved biosimilar for cancer. Experts predict that biosimilars will lead to lower drug prices, but caution that the savings won't be as dramatic as that seen with generics.
October 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28664508/correlation-between-expression-of-recombinant-proteins-and-abundance-of-h3k4me3-on-the-enhancer-of-human-cytomegalovirus-major-immediate-early-promoter
#20
Benjamin P C Soo, Julian Tay, Shirelle Ng, Steven C L Ho, Yuansheng Yang, Sheng-Hao Chao
Role of epigenetic regulation in the control of gene expression is well established. The impact of several epigenetic mechanisms, such as DNA methylation and histone acetylation, on recombinant protein production in mammalian cells has been investigated recently. Here we investigate the correlation between the selected epigenetic markers and five trastuzumab biosimilar-producing Chinese hamster ovary (CHO) cell lines in which the expression of trastuzumab is driven by human cytomegalovirus (HCMV) major immediate-early (MIE) promoter...
August 2017: Molecular Biotechnology
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