欧盟委员会批准前列腺癌新药Erleada(apalutamide):口服雄激素受体抑制剂

2019-01-27 MedSci MedSci原创

Erleada(apalutamide)已被批准用于治疗转移性疾病高风险的非转移性去势抵抗性前列腺癌(nmCRPC)患者。

Erleada(apalutamide)已被批准用于治疗具有转移高风险的非转移性去势抵抗性前列腺癌(nmCRPC)患者。

此批准是基于临床第3阶段SPARTAN研究的结果,该研究发表在"新英格兰医学杂志"上。

该研究评估了apalutamide加雄激素剥夺疗法(ADT)与安慰剂加ADT在nmCRPC患者中的有效性和安全性。

结果显示,与安慰剂联合ADT相比,apalutamide加ADT将远端转移或死亡率(MFS)降低72%。在前列腺抗原快速升高的nmCRPC患者中,MFS中位数改善超过两年(40.5个月对16.2个月)。

Apalutamide是一种口服雄激素受体(AR)抑制剂,可阻断前列腺癌细胞中的雄激素信号通路。Apalutamide以三种方式抑制癌细胞的生长:阻止雄激素与AR结合;阻止AR进入癌细胞; 并且阻止AR结合癌细胞的DNA。

在美国,apalutamide于2018年2月获得食品和药物管理局批准用于治疗nmCRPC患者,随后在加拿大、澳大利亚、阿根廷和巴西获得批准。

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    2019-06-16 jklm09
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    2019-01-29 般若傻瓜
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    2019-01-29 zhaojie88
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