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安斯泰来向日本MHLW提交前列腺癌新药enzalutamide MAA

来源:生物谷 2013-05-25 00:26

2013年5月24日讯 /生物谷BIOON/ --安斯泰来(Astellas)和Medivation制药今天宣布,已向日本卫生劳动福利部(MHLW)提交了Xtandi(enzalutamide)的上市许可申请(MAA),寻求批准用于既往经基于多西紫杉醇化疗的晚期阉割性前列腺癌患者的治疗。

Enzalutamide是一种新颖的、每日一次的口服雄激素受体信号传导抑制剂,该药能够抑制雄激素受体信号传导通路中的多个步骤,已被证明能够降低癌细胞的生长,并能诱导肿瘤细胞死亡。

去年8月底,enzalutamide已获FDA批准用于已扩散或复发的晚期(转移性)阉割性前列腺癌患者的治疗。

该药MAA的提交,主要基于一项全球性III期临床试验(AFFIRM)及在日本开展的I-II期临床试验的数据。

AFFIRM是一项多国、双盲、安慰剂对照III期试验,在既往经基于多西紫杉醇化疗的晚期阉割性前列腺癌患者中开展。

I-II期临床试验为开放标签研究,I期试验在晚期阉割性前列腺癌患者中开展,II期试验在既往经基于多西紫杉醇化疗的晚期阉割性前列腺癌患者中开展。(生物谷bioon.com)

英文原文:Astellas and Medivation Announce Submission of Application for Marketing Approval of Enzalutamide, an Oral Androgen Receptor Inhibitor, in Japan

May 24, 2013 Tokyo, Japan and San Francisco, CA – May 24, 2013 – Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) today announced that Astellas has submitted an application for marketing approval of enzalutamide (generic name) to the Ministry of Health, Labour and Welfare in Japan for the treatment of prostate cancer.

Enzalutamide is a novel, once-daily, oral androgen receptor signaling inhibitor. It inhibits multiple steps in the androgen receptor signaling pathway, which has been shown to decrease cancer cell growth and can induce cancer cell death (apoptosis).

This filing application is based mainly on results obtained from the global Phase 3 trial (the AFFIRM trial)* and a Phase 1-2 trial conducted in Japan** .

* A multi-country, double-blind, placebo-controlled study in patients with advanced castration-resistant prostate cancer who had previously undergone docetaxel-based chemotherapy.

** An open-label, study. Phase 1 enrolled patients with advanced castration-resistant prostate cancer and Phase 2 enrolled patients with advanced castration-resistant prostate cancer who had received docetaxel therapy.

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