拜耳(BAYRY.US)“达罗他胺”新适应症在美申报上市

智通财经11-22

智通财经APP获悉，11月21日，拜耳(BAYRY.US)宣布其达罗他胺(商品名：Nubeqa)联合雄激素剥夺疗法(ADT)治疗转移性激素敏感性前列腺癌(mHSPC)患者的补充新药申请(sNDA)获FDA受理。此次sNDA是基于III期ARANOTE研究的积极结果。该研究是一项随机、双盲、安慰剂对照临床试验(n=669)，评估了达罗他胺(600mg，每日2次)联合ADT对比安慰剂联合ADT治疗...

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