更新版 1-试验失败后,吉利德公司在美国撤回膀胱癌药物

Reuters
18 Oct 2024

((自动化翻译由路透提供,请见免责声明 )) (在第 4 段中增加了股票走势,在第 2、3、5 段中增加了背景和详细信息)

路透10月18日 - 吉利德科学公司(Gilead Sciences )周五表示,在与美国卫生监管机构协商后,该公司将自愿撤回其用于先前治疗过的一种膀胱癌患者的药物Trodelvy。

美国食品和药物管理局曾于 2021 年加速批准 Trodelvy(一种抗体药物共轭物)用于转移性尿路上皮癌的治疗,但是否继续批准取决于一项确证试验的结果。

然而,该药物在试验中未能改善晚期膀胱癌患者的生存率。

该制药商的股票在盘前交易中下跌了 1.3%,至 86.25 美元。

该公司表示,这一决定不会影响Trodelvy在美国境内或境外用于其他患者的审批。

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