Myovant口服促性腺激素释放激素拮抗剂relugolix的前列腺癌III期试验成功

2019-11-22 不详 MedSci原创

Myovant宣布了其III期HERO研究的阳性结果,该研究对晚期前列腺癌患者中评价了每日一次口服relugolix的疗效。在该数据的支持下,该公司将于2020年第二季度向美国食品和药物管理局(FDA)提交新药申请(NDA)。

Myovant宣布了其III期HERO研究的阳性结果,该研究对晚期前列腺癌患者中评价了每日一次口服relugolix的疗效。在该数据的支持下,该公司将于2020年第二季度向美国食品和药物管理局(FDA)提交新药申请(NDA)。

该试验达到了主要疗效终点和所有六个主要次要终点,每天接受relugolix治疗的男性中有96.7%的人将睾丸激素持续抑制到去势水平。

此外,该药物在48周的持续睾丸激素抑制作用下显示出不劣于leuprolide acetate的效果-分别为96.7%和88.8%-组间差异为7.9%。药效学结果还显示,在开始relugolix治疗后,没有睾丸激素耀斑,并且平均睾丸激素水平在治疗中断后的90天内恢复到正常水平。

卡罗莱纳州泌尿学研究中心医学主任兼HERO计划指导委员会成员尼尔·肖尔说,口服促性腺激素释放激素(GnRH)拮抗剂用于治疗晚期前列腺癌已经被期待多年。如果获得批准,relugolix将成为晚期前列腺癌男性的首个口服选择。

晚期前列腺癌的治疗通常涉及雄激素剥夺疗法,该疗法可将睾丸激素降低至非常低的水平,通常称为去势水平。

每年英国大约有47700个新的前列腺癌病例,相当于每天约130个,占英国男性所有新诊断癌症病例的26%。

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    2019-11-22 misszhang

    前列腺癌相关研究,学习了,谢谢梅斯

    0