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Drugs. 2018 Nov;78(16):1751-1755. doi: 10.1007/s40265-018-0997-0.
Pyrotinib is an irreversible dual pan-ErbB receptor tyrosine kinase inhibitor developed for the treatment of HER2-positive advanced solid tumours. Based on positive results in a phase II trial, the drug recently received conditional approval in China for use in combination with capecitabine for the treatment of HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or taxane chemotherapy. This article summarizes the milestones in the development of pyrotinib leading to this first global approval for the treatment of HER2-positive advanced breast cancer.
吡咯替尼是一种不可逆的双靶点人表皮生长因子受体 2（HER2）酪氨酸激酶抑制剂，用于治疗 HER2 阳性晚期实体瘤。基于 II 期临床试验的积极结果，该药最近在中国有条件批准与卡培他滨联合用于治疗既往接受过蒽环类或紫杉类化疗的 HER2 阳性、晚期或转移性乳腺癌患者。本文总结了吡咯替尼的开发历程中的重要里程碑，最终使其在全球范围内首次获批用于治疗 HER2 阳性晚期乳腺癌。
