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FDA授予安斯泰来前列腺癌药物Xtandi sNDA优先审查资格

2014年5月8日讯 /生物谷BIOON/ --安斯泰来(Astellas)和Medivation制药5月6日宣布,FDA已授予前列腺癌药物Xtandi(enzalutamide)补充新药申请(sNDA)优先审查资格。该药sNDA的提交,旨在扩大Xtandi的适应症,用于既往未接受化疗的转移性去势性前列腺癌(mCRPC)男性患者的治疗。FDA已指定Xtandi sNDA的处方药用户收费法(PDUFA)日期为2014年9月18日。

目前,Xtandi已获批用于既往接受过多西紫杉醇化疗的转移性去势性前列腺癌(mCRPC)的治疗。

Xtandi sNDA的提交,是基于III期PREVAIL试验的数据,该项研究在超过1700例化疗初治(chemotherap-naive)mCRPC患者中开展,调查了Xtandi相对于安慰剂的疗效。此前,安斯泰来已于2014年4月2日向欧洲药品管理局(EMA)提交了Xtandi上市许可申请(MAA)的一个变更申请。

关于Xtandi(enzalutamide):

enzalutamide商品名为Xtandi,该药属于一类名为雄性激素抑制剂的新药,旨在干扰睾酮结合前列腺癌细胞的能力。睾酮是一种男性激素,能够激化前列腺癌细胞的生长。

Xtandi于今年8月31日获得了FDA批准,用于经激素疗法及化疗后癌症已扩散的男性前列腺癌患者的治疗。(生物谷Bioon.com)

英文原文:Astellas and Medivation Receive Priority Review From FDA for XTANDI(R) (Enzalutamide) Capsules in Chemotherapy-Naive Advanced Prostate Cancer

SAN FRANCISCO, CA and TOKYO, JAPAN -- (Marketwired) -- 05/06/14 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI? (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-na?ve mCRPC patients. A variation application to amend the European Marketing Authorization Application was submitted to the European Medicines Agency on April 2, 2014.

The FDA's acceptance of the sNDA triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

About the PREVAIL Trial
The Phase 3 PREVAIL trial is a randomized, double-blind, placebo-controlled, multi-national trial that enrolled more than 1,700 patients at sites in the United States, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan. The trial enrolled patients with chemotherapy-na?ve metastatic prostate cancer whose disease progressed on a luteinizing hormone-releasing hormone analogue or after bilateral orchiectomy. The co-primary endpoints of the trial were overall survival and radiographic progression-free survival. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo.

Enzalutamide Mechanism of Action
Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA.

About XTANDI? (enzalutamide) capsules
XTANDI was approved by the FDA on August 31, 2012 and is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.

关键词:安斯泰来,Medivation,前列腺癌,Xtandi,enzalutamide

信息来源:生物谷