曲妥珠单抗生物仿制药治疗HER-2阳性乳腺癌的临床研究进展  

Clinical research progress of trastuzumab biosimilars in HER-2 positive breast cancer

作　　者：尚玲敏 程绍强[1] SHANG Lingmin;CHENG Shaoqiang(Harbin Medical University Cancer Hospital,Heilongjiang Harbin 150081,China.)

机构地区：[1]哈尔滨医科大学附属肿瘤医院,黑龙江哈尔滨150081

出　　处：《现代肿瘤医学》2022年第9期1675-1679,共5页Journal of Modern Oncology

基　　金：国家自然科学基金资助项目(编号:8167111264)。

摘　　要：近年来,研究证明曲妥珠单抗可以显著改善人表皮生长因子受体-2(human epidermal growthfactor receptor 2,HER-2)阳性乳腺癌患者的生存预后,但由于其价格高昂,使患者选择受限。曲妥珠单抗生物仿制药的诞生有望节约成本、增加药物可及性,近年来已得到迅速发展。YL-1401O(Ogivri)、CT-P6(Herzuma)、SB3(Ontruzant)、PF-05280014(Trazimera)和ABP980(Kanjinti),它们现已被美国食品药品监督管理局(Food and Drug Administration,FDA)批准用于HER-2阳性乳腺癌;我国HLX02已被欧洲药品管理局(The European Medicines Agency,EMA)和国家药品监督管理局(National Medical Products Administration,NMPA)批准上市。本文就近几年曲妥珠单抗生物仿制药在HER-2阳性乳腺癌中的研究进展进行综述,以期为HER-2阳性乳腺癌的靶向治疗提供参考。In recent years,studies have shown that trastuzumab can significantly improve for the survival of patients with human epidermal growth factor receptor 2(HER-2)positive breast cancer.Due to its high cost,make the patient choice is limited.Trastuzumab biosimilars,which are expected to reduce costs and increase access to drugs,have developed rapidly in recent years.YL-1401O(Ogivri),CT-P6(Herzuma),SB3(Ontruzant),PF-05280014(Trazimera)and ABP980(Kanjinti)have been approved by the U.S.Food and Drug Administration for HER-2 positive breast cancer.HLX02 has been approved for marketing by The European Medicines Agency(EMA)and National Medical Products Administration(NMPA)in China.In this paper,the research progress of trastuzumab biosimilar in HER-2 positive breast cancer was reviewed in recent years,in order to provide reference for targeted therapy of HER-2 positive breast cancer.

关 键 词：HER-2阳性乳腺癌 曲妥珠单抗 曲妥珠单抗生物仿制药 等效性 

分 类 号：R737.9[医药卫生—肿瘤]