FDA批准罗氏的乳腺癌双靶向HER2抗体组合:帕妥珠单抗与曲妥珠单抗

2020-07-01 MedSci原创 MedSci原创

这是罗氏首次获批将两种单克隆抗体,通过单次皮下注射进行给药。

美国监管机构已批准罗氏Phesgo(Pertuzumab,帕妥珠单抗)与Herceptin(Trastuzumab,曲妥珠单抗)和透明质酸酶的固定剂量组合,用于治疗早期和转移性HER2阳性乳腺癌。这是罗氏首次获批将两种单克隆抗体,通过单次皮下注射进行给药。该疗法与静脉(IV)注射的化疗联合给药。

See the source image

图片来源:http://www.cancernetwork.com/oncology-journal/pertuzumab-and-its-accelerated-approval-evolving-treatment-paradigms-and-new-challenges-management

Perjeta是一种新型抗HER2药物,通过抑制HER2异源性和同源性二聚体发挥抗HER2作用。Perjeta和Herceptin的作用机制相同,均靶向结合HER2受体,但所结合的部位不同。将2者联合用药,能够对HER2信号传导通路提供更全面的封锁,从而阻止癌细胞的生长和存活。

初始剂量的Phesgo皮下给药需要大约8分钟,随后的每次维持给药大约需要5分钟,相比之下,使用标准IV制剂连续输注Perjeta和Herceptin需要150分钟,维持给药则需要60-150分钟。

罗氏还表示,Phesgo可以由医护人员在治疗中心或患者在家中自行管理

Phesgo的批准基于FeDeriCa III期研究的数据,该研究达到了其主要终点,结果显示与静脉注射相比,皮下注射后血液中Perjeta的含量呈现非劣等性。

罗氏强调,Phesgo联合化疗的安全性与Perjeta联合赫赛汀和化疗相当,并且未发现新的安全信号。

原始出处:

http://www.pharmatimes.com/news/us_nod_for_roches_breast_cancer_combo_1343311

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    2021-06-15 bugit
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    2020-07-01 mswert122

    #乳腺癌#双妥方案皮下使用

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