Zobrazeno 1 - 7 of 7 pro vyhledávání: '"Ye Chan Yoon"'
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SB8, an approved bevacizumab biosimilar based on totality of evidence : scientific justification of extrapolation
Autor: Marc Peeters, Hans-Peter Lipp, Minjeong Park, Ye Chan Yoon, Dirk Arnold
Publikováno v: Future oncology
SB8 is a biosimilar of bevacizumab based on its similarity demonstrated by physicochemical, functional, non-clinical and clinical studies. Supported by the concept of extrapolation, SB8 was authorized and is used in a similar manner across all types
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac7a52dbf0b49fb62347fc770ce4b10f
https://hdl.handle.net/10067/1951690151162165141
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Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer
Autor: Younsoo Kim, Xavier Pivot, Igor Bondarenko, Diana Lüftner, Giuseppe Curigliano, Chul Kim, Javier Cortes, Ye Chan Yoon, Gary H. Lyman, Mark D. Pegram
Publikováno v: European journal of cancer (Oxford, England : 1990). 120
Background We assessed long-term cardiac safety and efficacy in patients with human epidermal growth factor receptor 2–positive early breast cancer treated with a trastuzumab biosimilar (SB3) or its reference product, trastuzumab (TRZ), in a phase
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a42ce5e7dcf6464ff39096d4f37fc361
https://pubmed.ncbi.nlm.nih.gov/31445454
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4
Four-year follow-up of a phase III study comparing SB3 (trastuzumab biosimilar) and reference trastuzumab in HER2-positive early or locally advanced breast cancer in neoadjuvant setting
Autor: Younsoo Kim, Xavier Pivot, Mikhail Dvorkin, Chul Kim, Diana Lüftner, Hope S. Rugo, Mark D. Pegram, Giuseppe Curigliano, Javier Cortes, Ye Chan Yoon, Gary H. Lyman, Igor Bondarenko
Publikováno v: Journal of Clinical Oncology. 38:578-578
578 Background: SB3 was approved in the US and EU as a biosimilar of reference trastuzumab (TRZ). Here, we report 4-year cardiac safety and survival outcomes. Methods: After completing neoadjuvant-adjuvant therapy in patients with HER2 positive early
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ce4ce65e366fb3f8f05e99a1c38f14c2
https://doi.org/10.1200/jco.2020.38.15_suppl.578
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5
Evaluation of survival by ADCC status: Subgroup analysis of SB3 (Trastuzumab Biosimilar) and reference trastuzumab in patients with HER2-positive early breast cancer at three-year follow-up
Autor: Igor Bondarenko, Diana Lüftner, Javier Cortes, Xavier Pivot, Ye Chan Yoon, Gary H. Lyman, Giuseppe Curigliano, Jae Yun Lim, Younsoo Kim, Mark D. Pegram
Publikováno v: Journal of Clinical Oncology. 37:580-580
580 Background: SB3 is an approved biosimilar of reference trastuzumab (TRZ). At additional 2-year follow-up after completing neoadjuvant and adjuvant treatment, there was a difference in event-free survival (EFS), but no difference in overall surviv
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::95c7422877000f3048fba1bab6a2d3cf
https://doi.org/10.1200/jco.2019.37.15_suppl.580
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