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多拉米胺Darolutamide在欧盟申请上市,用于治疗非转移性去势抵抗性前列腺癌

2019-03-11 不详 MedSci原创

这一申请是基于3期临床试验ARAMIS的阳性数据。研究结果显示,darolutamide联合雄激素剥夺疗法(ADT)的无转移生存率(MFS)有统计学意义上的显着改善,结果同时在"新英格兰医学杂志"和美国临床肿瘤学会泌尿生殖系统癌症研讨会(ASCO GU)上发表。

Orion和Bayer公司已经在欧洲提交了一份营销申请,将多拉米胺darolutamide用于治疗非转移性去势抵抗性前列腺癌患者。

这一申请是基于3期临床试验ARAMIS的阳性数据。研究结果显示,darolutamide联合雄激素剥夺疗法(ADT)的无转移生存率(MFS)有统计学意义上的显着改善,结果同时在"新英格兰医学杂志"和美国临床肿瘤学会泌尿生殖系统癌症研讨会(ASCO GU)上发表。

Darolutamide是一种非甾体雄激素受体(AR)拮抗剂,具有独特的化学结构,可以与受体高亲和力结合,具有强烈的拮抗活性,从而抑制受体功能和前列腺癌细胞的生长。

它尚未获得美国食品药品管理局(FDA)、欧洲药品管理局或任何其他卫生机构的批准。

Orion研发高级副总裁Christer Nordstedt说:"Darolutamide对非转移性去势抵抗性前列腺癌的患者非常有效,并且其副作用与安慰剂相似。接受darolutamide治疗的患者在ARAMIS试验中的MFS明显延长,并且总体存活率也有提高的趋势。"

前列腺癌是全球男性中第二常见的恶性肿瘤,2018年全世界约有120万男性被诊断患有前列腺癌,358000人死于该疾病。

原始出处:


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    2019-11-13 yige2012
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darolutamide联合雄激素剥夺疗法在非转移性去势抵抗性前列腺癌中显著延长了PFS

对于非转移性去势抵抗性前列腺癌(nmCRPC)患者,关键性III期ARAMIS试验的结果显示,与安慰剂联合雄激素剥夺疗法(ADT)相比,使用拜耳的研究性药物darolutamide联合ADT的无转移生存率(MFS)有统计学意义上的显著改善(HR = 0.41,95%CI 0.34-0.50;P <0.001)。这意味着转移或死亡风险降低了59%。

Darolutamide治疗非转移性去势抵抗性前列腺癌已向FDA滚动提交完成

Orion和Bayer已完成向美国食品和药物管理局(FDA)滚动提交darolutamide的新药申请(NDA)。该申请时基于III期临床试验ARAMIS的数据,结果显示darolutamide与雄激素剥夺疗法(ADT)联用治疗非转移性去势抵抗性前列腺癌(nmCRPC)患者时,无转移性生存(MFS)在统计学上显着改善。

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