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来那替尼(neratinib,商品名NERLYNX)为Puma生物科技公司开发的HER酪氨酸激酶抑制剂(tyrosine kinase inhibitor,TKI)。2017年7月17日,FDA批准其用于早期HER_2阳性乳腺癌的延长性辅助治疗(extended adjuvant therapy)。对于该类型的癌症,来那替尼为首个延长性辅助治疗药物,可降低HER_2阳性乳腺癌的相关复发风险。笔者就来那替尼的研发历程、基本信息、作用机制、药动学、药效学、临床试验及应用等研发动态作一概述,以期能为医院临床用药起到指导作用。
Neratinib (NERLYNX) is a tyrosine kinase inhibitor (TKI) developed by Puma Biotech. On July 17, 2017, the FDA approved its extended adjuvant therapy for early HER2-positive breast cancer. In this type of cancer, neratinib is the first adjuvant extended-duration adjuvant to reduce the risk of relapse in HER2-positive breast cancers. The author came to ninitin’s R & D process, basic information, mechanism of action, pharmacokinetics, pharmacodynamics, clinical trials and applications such as R & D developments made a summary, with a view to the hospital for clinical use play a guiding role.