复发难治肾细胞癌的治疗或迎新突破:FDA已批准Tivozanib的NDA

2020-06-02 Allan MedSci原创

制药公司AVEO今日宣布,美国FDA批准了Tivozanib治疗复发难治肾细胞癌(RCC)的新药申请(NDA)。

制药公司AVEO今日宣布,美国FDA批准了Tivozanib治疗复发难治肾细胞癌(RCC)的新药申请(NDA),Tivozanib是该公司的下一代血管内皮生长因子受体酪氨酸激酶抑制剂(VEGFR-TKI)。在临床前模型中,Tivozanib可显著降低调节性T细胞的产生,并在II期研究中证明与nivolumab(抗PD-1抗体)联合使用具有协同作用。目前已经对Tivozanib治疗多种肿瘤类型进行了研究,包括肾细胞癌、肝细胞癌、结直肠癌、卵巢癌和乳腺癌。

AVEO总裁兼首席执行官Michael Bailey说:“FDA的批准是AVEO的又一个重要里程碑,我们期待着在接下来的几个月中与FDA紧密合作”。

FDA的此项批准是基于关键性III期试验(TIVO-3研究)的最新结果,该研究比较了tivozanib与sorafenib在第3和第4线RCC治疗中的有效性和安全性。III期试验(TIVO-1研究)还比较了tivozanib与sorafenib在第1线RCC治疗中的有效性和安全性。

 

原始出处:

https://www.firstwordpharma.com/node/1728972?tsid=4

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