安斯泰来（Astellas）和Medivation公司3月18日联合宣布，已向FDA提交了前列腺癌药物Xtandi（enzalutamide）补充新药申请（sNDA），寻求批准Xtandi用于未接受过化疗的转移性去势性前列腺癌（mCRPC）男性患者的治疗。目前，Xtandi已获批用于既往接受过多西紫杉醇化疗的mCRPC患者的治疗。
该药sNDA的提交，是基于III期PREVAIL研究的数据。该项研究在超过1700例既往未接受化疗的mCRPC患者中开展，将Xtandi与安慰剂进行了对比。安斯泰来和Medivation预计将于今年晚些时候向欧盟提交Xtandi的上市许可申请。
关于
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，旨在干扰睾酮结合前列腺癌细胞的能力，该药已被证明能够降低癌细胞的生长，并能诱导肿瘤细胞死亡。
enzalutamide已于2012年8月获FDA批准用于既往接受过多西紫杉醇疗法的转移性阉割性前列腺癌（mCRPC）患者的治疗。
TOKYO, JAPAN and SAN FRANCISCO, CA -- (Marketwired) -- 03/18/14 -- Astellas Pharma Inc. (TSE: 4503) and Medivation Inc. (NASDAQ: MDVN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI® (enzalutamide) capsules for the treatment of men with me-tastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. 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 eva1uating XTANDI as compared to placebo in more than 1,700 chemotherapy-naïve mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.
ab0ut 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-naïve me-tastatic 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 eva1uate 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.
ab0ut XTANDI® (enzalutamide) capsules
XTANDI was approved by the FDA on August 31, 2012 and is indicated for the treatment of patients with me-tastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.
imp0rtant Safety Information for XTANDI (from the approved prescribing information)
Contraindications - XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.
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