罗氏(RHHBY.US)Inavolisib在美上市申请获FDA优先审评

智通财经05-29

智通财经APP获悉，5月29日，罗氏(RHHBY.US)宣布Inavolisib在美国的上市申请获得优先审评资格，与哌柏西利和氟维司群联用治疗PIK3CA突变、HR+、HER2-的局部晚期或转移性乳腺癌成人患者，这些患者在完成辅助内分泌治疗后12个月内复发。PDUFA日期为 2024年11月27日。去年12月，罗氏宣布III期临床试验INAVO120研究取得阳性结果。表明inavolisib联合...

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