FDA批准靶向Trop-2的ADC药物Trodelvy,治疗三阴性乳腺癌

2020-04-25 MedSci原创 MedSci原创

Trodelvy是第一个靶向Trop-2的抗体-药物偶联物(ADC),也是针对三阴性乳腺癌第一个获批的ADC药物。

Immunomedics的抗体-药物偶联物Trodelvy(sacituzumab govitecan)获得FDA批准,用于治疗三阴性乳腺癌(TNBC)。Trodelvy在一年前遭FDA拒绝,被要求提供更多数据,但此次却获得了加速批准。

Trodelvy是第一个靶向Trop-2的抗体-药物偶联物(ADC),Trop-2是在多种实体瘤中过表达的糖蛋白抗原。该药物也是针对TNBC第一个获批的ADC药物。Trodelvy的2期研究结果显示TNBC患者的客观缓解率为33.3%,中位缓解时间为7.7个月。

TNBC患者的雌激素受体,孕激素受体和HER2呈阴性,因此他们对激素治疗药物或曲妥珠单抗等靶向HER2的药物无应答。

FDA已批准Trodelvy用于已扩散(已转移)至身体其他部位并且先前已接受过至少两种药物治疗的TNBC患者。

多年来,TNBC的主要治疗手段一直是化学疗法,去年罗氏(Roche)的PD-1单抗Tecentriq(atezolizumab)成为首个获得治疗该类癌症的免疫疗法。

原始出处:

http://www.pmlive.com/pharma_news/immunomedics_nabs_speedy_fda_approval_for_triple-negative_breast_cancer_drug_1338829

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