Miller Emily M, Schwartzberg Lee S
Division of Hematology/Oncology, Department of Medicine, University of Tennessee Health Science Center, Germantown, TN, USA.
West Cancer Center, 7945 Wolf River Boulevard, Germantown, TN 38183, USA. Division of Hematology/Oncology, Department of Medicine, University of Tennessee Health Science Center, Germantown, TN, USA.
Ther Adv Med Oncol. 2019 Nov 14;11:1758835919887044. doi: 10.1177/1758835919887044. eCollection 2019.
The utilization of trastuzumab biosimilar medications is of particular interest in HER2-positive breast cancer as these drugs have the potential for cost savings and increased utilization/access to HER2 targeted therapy in both early stage and metastatic HER2-positive breast cancers. Five trastuzumab biosimilars: MYL-1401O (Ogivri), CT-P6 (Herzuma), SB3 (Ontruzant), PF-05280014 (Trazimera), and ABP980 (Kanjinti), have now been approved by the US Food and Drug Administration (FDA) for use in HER2-positive breast cancers. This review provides an overview of these agents with special consideration of the development and approval process, including available clinical data results for these trastuzumab biosimilars. Adoption in the clinic will depend on the degree of comfort with the overall evidence.
曲妥珠单抗生物类似药在HER2阳性乳腺癌中的应用备受关注，因为这些药物有可能节省成本，并在早期和转移性HER2阳性乳腺癌中提高HER2靶向治疗的利用率/可及性。五种曲妥珠单抗生物类似药：MYL-1401O（Ogivri）、CT-P6（Herzuma）、SB3（Ontruzant）、PF-05280014（Trazimera）和ABP980（Kanjinti），现已获得美国食品药品监督管理局（FDA）批准，用于HER2阳性乳腺癌。本综述概述了这些药物，并特别考虑了其研发和审批过程，包括这些曲妥珠单抗生物类似药的现有临床数据结果。临床应用将取决于对整体证据的接受程度。
