NMPA批准XTANDI(恩杂鲁胺软胶囊)治疗非转移性去势抵抗性前列腺癌

2020-11-08 Allan MedSci原创

制药公司Astellas近日宣布,中国国家药品监督管理局(NMPA)已批准XTANDI®(恩杂鲁胺软胶囊)治疗具有转移风险的非转移性去势抵抗性前列腺癌(nmCRPC)。

制药公司Astellas近日宣布,中国国家药品监督管理局(NMPA)已批准XTANDI®(恩杂鲁胺软胶囊)治疗具有转移风险的非转移性去势抵抗性前列腺癌(nmCRPC)。这是恩杂鲁胺在中国的第二个获批准的适应症,先前已被批准用于雄激素剥夺治疗(ADT)失败后无症状或轻度症状的转移性去势抵抗性前列腺癌(mCRPC)患者。

该批准是基于PROSPER试验的结果,该试验是一项双盲、安慰剂对照的III期试验,该试验评估了了恩杂鲁胺联合ADT与安慰剂联合ADT治疗nmCRPC患者的有效性和安全性。PROSPER研究达到了无转移生存(MFS)的主要终点,接受恩杂鲁胺联合ADT的男性患者的中位MFS为36.6个月,而安慰剂联合ADT的中位MFS仅有14.7个月。此外,与安慰剂联合ADT相比,接受恩杂鲁胺联合ADT的男性患者的影像学进展或死亡风险降低了71%(p <0.001)。

 

原始出处:

https://www.firstwordpharma.com/node/1771715?tsid=4

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    2021-07-18 yige2012
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    2021-03-02 lingaifan
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    2020-11-08 misszhang

    前列腺癌相关研究,学习了,谢谢梅斯

    0

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拓展阅读

JCO:FDA批准他拉唑帕利联合恩杂鲁胺用于治疗HRR基因突变的晚期去势抵抗性前列腺癌

该研究的主要目的是评估他拉唑帕利联合恩杂鲁胺在HRR基因突变晚期去势抵抗性前列腺癌患者一线治疗中的疗效和安全性,在全部入组和HRR突变人群中,他拉唑帕利+恩杂鲁胺组rPFS明显优于安慰剂+恩杂鲁胺组。

Cancer Res:中山大学李永红/周芳坚/王军发现前列腺癌恩杂鲁胺耐药的潜在机理

该研究利用全基因组CRISPR - Cas9文库筛选,发现靶向糖酵解酶磷酸甘油酸变位酶PGAM2,在体内和体外均显著增强了ENZ耐药前列腺癌细胞对ENZ的敏感性。

FDA批准他拉唑帕利+恩杂鲁胺,前列腺癌患者死亡风险降低55%!

Talazoparib是首个经证实与恩杂鲁胺联合使用可为mCRPC患者带来临床益处的PARP抑制剂,这将改变mCRPC患者的新标准治疗方法,为那些面临困境的mCRPC患者带来新的希望。

JCO:他拉唑帕利(TALA)加恩杂鲁胺(ENZA) vs 恩杂鲁胺(ENZA)加安慰剂一线治疗携带HRR基因突变的mCRPC患者

该研究旨在评估他拉唑帕利联合恩杂鲁胺一线治疗携带HRR基因突变的mCRPC患者的疗效和安全性,研究结果显示TALA+ENZA在rPFS方面比标准护理ENZA有统统计学意义和临床意义的改善。

Clin. Cancer Res:Sipuleucel-T 和醋酸阿比特龙或恩杂鲁胺联合治疗转移性去势抵抗性前列腺癌:STAMP 和 STRIDE 试验

该研究旨在对Sipuleucel-T 和醋酸阿比特龙或恩杂鲁胺联合治疗转移性去势抵抗性前列腺癌的疗效和安全性分析

Lancet:他拉唑帕尼加恩杂鲁胺治疗一线转移性去势抵抗性前列腺癌 (TALAPRO-2) 患者:一项随机、安慰剂对照的 3 期试验

该研究旨在评估他拉唑帕尼加恩杂鲁安作为一线治疗转移性去势抵抗性前列腺癌的疗效和安全性。