FDA批准曲妥珠单抗生物类似物Herzuma(曲妥珠单抗-pkrb)

2018-12-16 MedSci MedSci原创

美国食品和药物管理局(FDA)已经批准Herzuma(曲妥珠单抗-pkrb,Celltrion公司)作为Herceptin(曲妥珠单抗,Genentech公司)的生物类似物,用于HER2过表达的乳腺癌患者。Herzuma是HER2 / neu受体拮抗剂,用于治疗过度表达HER2的乳腺癌。

美国食品和药物管理局(FDA)已经批准Herzuma(曲妥珠单抗-pkrbCelltrion公司)作为Herceptin(曲妥珠单抗,Genentech公司)的生物类似物,用于HER2过表达的乳腺癌患者。HerzumaHER2 / neu受体拮抗剂,用于治疗过度表达HER2的乳腺癌。

Herzuma治疗HER2阳性乳腺癌的常见预期副作用包括头痛、腹泻、恶心、发冷、发烧、感染、充血性心力衰竭、失眠、咳嗽和皮疹。Herzuma预期的严重副作用包括化疗引起的中性粒细胞减少症的恶化。与Herceptin一样,Herzuma的标签包含一个不良反应警告,提醒医疗保健专业人员和患者注意心肌病风险的增加、输液反应、肺毒性和胚胎-胎儿毒性。


原始出处:

http://www.firstwordpharma.com/node/1611867?tsid=4#axzz5ZoUV0SOC

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    2019-02-02 gj0742

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