拜尔的雄激素受体拮抗剂Nubeqa在欧洲被授权,用于治疗非转移性前列腺癌

2020-04-01 MedSci原创 MedSci原创

欧盟委员会已授予拜耳(Bayer)口服非甾体雄激素受体拮抗剂Nubeqa(darolutamide)的销售许可,用于治疗非转移性去势抵抗性前列腺癌(nmCRPC)的男性患者。

欧盟委员会已授予拜耳(Bayer)口服非甾体雄激素受体拮抗剂Nubeqa(darolutamide)的销售许可,用于治疗非转移性去势抵抗性前列腺癌(nmCRPC)的男性患者。

此次授权是基于ARAMIS的III期试验数据,数据显示该药物与雄激素剥夺疗法(ADT)联合使用可显着改善无转移生存率(MFS)。中位分析结果为40.4个月,而安慰剂加ADT为18.4个月。

拜耳英国专业医学部医学事务主管Melissa Rowe说:"欧洲的医生现在有了一种新的治疗选择,其副作用可控,与单独使用安慰剂和ADT相比,该方法可延迟前列腺癌男性转移的发生。这种授权代表了在对抗前列腺癌方面的重要进步。"

前列腺癌仅限于前列腺区域,且在接受ADT治疗后体内睾丸激素水平下降到极低水平的情况下也能持续发展,称为非转移性CRPC。

拜耳提醒,根据2018年前列腺癌的发病率数据,在欧洲估计有6.7万多名男性患有CRPC。

原始出处:

http://www.pharmatimes.com/news/nubeqa_authorised_in_europe_for_certain_prostate_cancer_patients_1332707

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  5. 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  6. 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  9. 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  10. 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    2020-04-02 misszhang

    前列腺癌相关研究,学习了,谢谢梅斯

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