FDA Approves AVEO Oncology's Fotivda For Renal Cell Carcinoma

FDA批准AVEO肿瘤治疗肾癌

2021-03-11 18:00:23 RTTNews

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Shares of AVEO Oncology jumped about 20% in extended trading hours Wednesday after the company announced that the FDA approved Fotivda for the treatment of patients with relapsed or refractory advanced renal cell carcinoma. Fotivda is the first therapy approved for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. The company plans to make the treatment available to patients in the U.S. by March 31, 2021. Fotivda is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). The approval of Fotivda was based on AVEO's pivotal Phase 3 study, TIVO-3, comparing Fotivda to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. AVEO closed Wednesday's trading at $15.28, up $7.20 or 89.11%, on the Nasdaq. The stock further gained $3.08 or 20.16% in the after-hours trade. For comments and feedback contact: editorial@rttnews.com Business News
爱唯欧肿瘤公司股价周三在延长交易时间内大涨约20%,此前该公司宣布FDA批准Fotivda用于治疗复发或难治的晚期肾细胞癌患者。 Fotivda是首个被批准用于复发或难治性晚期肾细胞癌成人患者的治疗方案,这些患者经过两次或两次以上的系统治疗。该公司计划在2021年3月31日前向美国的患者提供这种治疗。 Fotivda是一种口服的,下一代血管内皮生长因子(VEGF)酪氨酸激酶抑制剂(TKI)。 Fotivda的批准是基于Aveo的关键3期研究TIVO-3,该研究比较了Fotivda和索拉非尼在两种或两种以上系统治疗后复发或难治的晚期肾癌中的疗效。该应用还得到了RCC的三个额外试验的支持,并包括了来自1000多名临床试验受试者的安全性数据。 AVEO周三在纳斯达克收盘报15.28美元,上涨7.20美元,涨幅为89.11%。该股在盘后交易中进一步上涨3.08美元,涨幅20.16%。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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