Astellas Announces the Approval of XTANDI® by the China National Medical Products Administration

安斯泰来宣布安可坦®(XTANDI®)获得国家药品监督管理局批准

2019-11-26 08:30:00 YAHOO!FINANCE

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Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer  Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the China National Medical Products Administration (NMPA) approved a new drug application (NDA) for XTANDI® (enzalutamide) on November 18 for the treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated.  The approval by the NMPA was based on the results of an Asian multinational Phase 3, randomized, double-blind, placebo controlled efficacy and safety study of enzalutamide in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who had disease progression despite ADT and a single-dose pharmacokinetic study in healthy Chinese volunteers (Protocol 9785-CL-0013).1 The study, Asian PREVAIL (also known as 9785-CL-0232), evaluated oral enzalutamide (160 mg/day) versus placebo plus gonadotropin-releasing hormone (GnRH) therapy or after bilateral orchiectomy. The study, involving Asian patients including approximately 200 Chinese patients, showed consistent results with those in the global pivotal Phase 3 PREVAIL study in the same target population.2 "Currently the treatment options are limited in China for men with metastatic castration-resistant prostate cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "The approval of enzalutamide in China brings us one step closer to offering physicians a meaningful treatment option in an area where there is a high medical need." Patients treated with enzalutamide demonstrated a statistically significant reduction in the risk of Prostate Specific Antigen (PSA) progression (Hazard Ratio of 0.38 [95% confidence interval: 0.27, 0.52], P < 0.0001). The median time to PSA progression was 8.31 months in the enzalutamide group versus 2.86 months in the placebo group. Treatment with enzalutamide also resulted in a statistically significant reduction in risk of radiographic disease progression or death compared with treatment with placebo with a Hazard Ratio (HR) of 0.31 (95% confidence interval: 0.20, 0.46; P<0.0001). Additionally, treatment with enzalutamide showed a statistically significant improvement in overall survival compared to treatment with placebo, with a 67% decrease in the risk of death (HR 0.33, [95% CI: 0.16, 0.67]; P=0.0015). The safety profile observed in the Asian PREVAIL study was generally consistent with previous clinical studies in patients with metastatic CRPC.2 The most common adverse reactions (≥10%) that occurred more frequently (≥2% over placebo) in the enzalutamide-treated patients from the randomized placebo-controlled clinical trials were asthenia/fatigue, decreased appetite, hot flush, arthralgia, dizziness/vertigo, hypertension, headache, and decreased weight. In addition to the Asian PREVAIL data involving a Chinese sub-population, the approval was supported by results from the global Phase 3 PREVAIL trial, which were published in the New England Journal of Medicine in 2014. The Phase 3 PREVAIL trial was 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 Asia including Japan.2 Enzalutamide is a standard of care for men with metastatic CRPC in countries where it is available. Since 2012, it has been prescribed to more than 420,000 patients worldwide.3 Prostate cancer is the second most common cancer in men worldwide4 and in China it has become the most common tumor in male urinary malignancies.5 "The approval of enzalutamide is an important milestone. Tens of thousands of Chinese patients with metastatic castration-resistant prostate cancer could potentially benefit from the reduced risk of disease progression and death found in the Asian PREVAIL study," said Hiroshi Hamaguchi, President, Astellas Greater China Commercial. "The approval also demonstrates a significant step forward for Astellas, with enzalutamide being the first Astellas oncology treatment approved in China." About Asian PREVAIL (9785-CL-0232)The Asian PREVAIL study involving a Chinese sub-population was a multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly MDV3100) in asymptomatic or mildly symptomatic participants with progressive metastatic prostate cancer who have disease progression despite ADT. The study enrolled 388 participants who were not previously treated with cytotoxic chemotherapy. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily on time to PSA progression as compared to placebo in chemotherapy-naïve participants with progressive metastatic prostate cancer who had failed ADT. The study completed its double-blind period and is now in the open-label period. About metastatic Castration-Resistant Prostate Cancer  Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.6 Metastatic CRPC is fatal, with a median survival of approximately 3-4 years for men starting treatment with ADT.7  About Enzalutamide8 Enzalutamide is an oral, once-daily androgen receptor signaling inhibitor. Enzalutamide directly targets the androgen receptors (AR) and exerts its effects on three steps of the AR signaling pathway: About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States. Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References: _____________________________1 An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants https://clinicaltrials.gov/ct2/show/NCT02294461?term=9785-CL-0232&rank=1. Last accessed September 2019.2 Beer T, Armstrong A et al.  Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. N Engl J Med 2014; 371:424-433.3 Data on file. Northbrook, IL: Astellas Inc.                  4 American Cancer Society. Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Last accessed September 2019. 5 Chinese guidelines for diagnosis and treatment of prostate cancer 2018. Chin J Cancer Res. 2019 Feb; 31(1): 67–83.6 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Last accessed November 2019.7 Mottet N, et al. Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard. Eur Urol. 2018;3:316-321.8 European Medicines Agency. Summary of Product Characteristics: Xtandi 40 mg soft capsules. http://ec.europa.eu/health/documents/community-register/2018/20181023142671/anx_142671_en.pdf. Last accessed October 2019. multimedia:http://www.prnewswire.com/news-releases/astellas-announces-the-approval-of-xtandi-enzalutamide-by-the-china-national-medical-products-administration-nmpa-300964935.html
亚洲 PRECVAIL 对转移性前列腺癌患者的研究 安斯泰来(Astellas Pharma) Inc .( TSE :4503,总裁兼首席执行官: Kenji Yasukawa , Ph.D .)“ Astellas ”)今天宣布,中国国家医药产品管理局( NMPA )于11月18日批准了 XTANDI ®(恩扎鲁胺)的新药申请( NDA ),用于治疗成年男性转移性蓖麻抗前列腺癌( CRPC )患者,这些患者在雄激素剥夺治疗失败后无症状或轻度症状,目前还没有临床上显示化疗。 NMPA 的批准是基于一个亚洲多国3期,随机,双盲,在安慰剂症状或轻度症状的进展性转移性前列腺癌患者中,尽管存在 ADT ,但病情仍有进展,并且在健康的中国志愿者中进行了单剂量药代动力学研究(协议9785-CL-0013)。1 这项研究,亚洲 PRECVAIL (也称为9785-CL-0232),评价口服酶抑制剂(160mg /天)与安慰剂联合促性腺激素释放激素( GnRH )治疗或双侧睾丸切除后。这项研究涉及亚洲患者,包括大约200名中国患者,结果与全球关键的3期 PRECVAIL 研究在相同的目标人群中一致。2 Astellas 肿瘤学发展高级副总裁兼全球治疗区负责人 AndrewKrivoshik 医学博士(M.D.)博士说:“目前,中国对转移性抗铸件前列腺癌患者的治疗选择有限。”“在中国,恩扎鲁胺的批准让我们向医生提供了一个有意义的治疗选择,在一个医疗需求很高的地区。” 使用恩扎鲁胺治疗的患者显示前列腺特异性抗原( PSA )进展的风险有统计学意义的降低(危险比为0.38[95%置信区间:0.27,0.52], P <0.0001)。恩扎鲁胺组 PSA 进展的中位数时间为8.31个月,而安慰剂组为2.86个月。与安慰剂组相比,恩扎鲁胺治疗还可显著降低放射性疾病进展或死亡的风险,其危害比( HR )为0.31(95%置信区间:0.20,0.46; P <0.0001)。此外,与安慰剂相比,恩扎拉胺治疗显示总体生存率有统计学意义的改善,死亡风险降低67%( HR 0.33,[95% CI :0.16,0.67]; P =0.0015)。 亚洲 PRECVAIL 研究中观察到的安全性概况与先前的转移性 CRPC 患者的临床研究基本一致。2随机安慰剂对照临床试验的恩扎鲁胺治疗组最常见的不良反应(≥10%)发生频率(≥2%)以上的为乏力/疲劳、食欲下降、潮热、关节痛、头晕/眩晕、高血压、头痛、体重下降。 除了涉及中国亚人群的亚洲 PRECVAIL 数据外,该批准还得到了2014年《新英格兰医学杂志》发表的全球第3期 PRECVAIL 试验结果的支持。3期 PRECVAIL 试验是一项随机、双盲、安慰剂对照、多国试验,在美国、加拿大、欧洲、澳大利亚、俄罗斯、以色列和包括日本在内的亚洲地区招募了1700多名患者。2 恩扎鲁胺是一种标准的照顾男性转移性 CRPC 在有它的国家。自2012年以来,全球已有420,000多名患者使用该药物。前列腺癌是世界上第二大最常见的癌症,在中国已成为男性泌尿系统恶性肿瘤中最常见的肿瘤。5、5 “批准恩扎鲁胺是一个重要的里程碑。在亚洲 PRECVAIL 研究中发现,有数以万计的中国转移性抗铸件前列腺癌患者可能受益于疾病进展和死亡风险的降低。这一批准也标志着 Astellas 向前迈出了重要的一步,在中国批准的首个 Astellas 肿瘤治疗药物是酶那度胺。 关于亚洲 PRECVAIL (9785-CL-0232)涉及中国亚群的亚洲 PRECVAIL 研究是一个多阶段3,随机,双盲,安慰剂对照的疗效和安全性研究口服恩扎拉胺(前 MDV3100)在无症状或轻度症状参与人进展性转移性前列腺癌谁有疾病进展尽管 ADT 。这项研究招收了388名以前没有接受过细胞毒性化疗的参与者。该试验的目的是评估恩扎拉胺的剂量为160毫克每天口服一次 PSA 进展,与安慰剂相比,化疗-纳伊韦参与者的进展性转移性前列腺癌谁 ADT 失败。这项研究完成了双盲期,目前正处于开放时期。 关于转移性抗 Castation-Resistant 前列腺癌前列腺癌,前列腺癌一旦扩散到前列腺以外的身体其他部位,就被认为是转移性前列腺癌。6转移性 CRPC 是致命的,中位生存期约3-4年的男性开始治疗 ADT 。7 关于恩扎鲁胺8恩扎鲁胺是一种口服的,每日一次的雄激素受体信号抑制剂。恩扎鲁胺直接作用于雄激素受体( AR ),并对 AR 信号通路的三个步骤发挥作用: 关于 AstellasAstellas Pharma Inc .,总部位于日本东京,是一家致力于通过提供创新可靠的医药产品来改善世界各地人民健康的公司。详情请访问我们的网站: https://www.astellas.com/en 。 关于辉瑞(Pfizer)与 Astellas 的合作2009年10月, Medivation , Inc .与 Astellas ( TSE :4503)达成了一项全球协议,共同开发和商业化酶那度胺。在美国和 Astellas 联合商业化的公司负责在全球范围内制造和所有额外的监管申报,以及在美国以外的地区商业化氮卓拉胺。 注意事项在本新闻稿中,对目前的计划、估计、战略和信念以及其他不属于历史事实的陈述是对 Astellas 未来业绩的前瞻性陈述。该等陈述乃根据管理层根据其目前可获得的资料所作出的现时假设及信念,并涉及已知及未知的风险及不明朗因素。若干因素可能导致实际结果与前瞻性陈述中讨论的结果存在重大差异。这些因素包括但不限于:( i )与医药市场有关的一般经济条件和法律法规的变化;( ii )货币汇率波动;( iii )新产品上市延迟;( iv ) Astellas 无法有效地销售现有和新产品,( v ) Astellas 无法继续有效地研究和开发客户在竞争激烈的市场接受的产品,以及( vi )第三方侵犯 Astellas 的知识产权。 本新闻稿中包含的有关医药产品(包括目前正在研发的产品)的信息无意构成广告或医学建议。 参考资料: ________________________________________________________________________一项亚洲研究,评价口服恩扎鲁胺在进展性转移性前列腺癌患者中的疗效和安全性。gov / ct2/ show / NCT02294461?术语=9785-CL-0232&秩=1。最后一次访问2019年9月2日啤酒 T ,阿姆斯特朗等人。恩扎鲁胺在化疗前转移性前列腺癌中的应用.N Engle J Med 2014;371:424-433.3文件数据。美国癌症学会(American Cancer Society).前列腺癌的关键统计数据.https://www.cancer.org/cancer/前列腺癌/about/key-statistics 。html 。上一次访问了2019年9月。5中国前列腺癌诊断和治疗指南。中华癌症研究中心.2019年2月31日(1):67-83.6美国临床肿瘤学会.ASCO 答案:前列腺癌(2018年)。http://www.cancer.net/sites/cancer 。net / files / asco _ response _ Guide _前列腺。pdf 。最后一次访问是2019年11月7日。更新的激素敏感前列腺癌转移指南:阿比特隆醋酸盐联合铸造是另一个标准。Eur Urol 。2018年;3:316-321.8欧洲药品管理局。产品特点总结: Xtandi 40毫克软胶囊。http://ec 。欧罗巴。EU / health / documents / community-register /2018/2018102314671/ anx _142671_en 。pdf 。最后一次访问是2019年10月。 多媒体: http://www.prnewswire.com/news-releases/astellas-annound-of-xtandi-enzalutaminde-by-China-national-medical-products-Administration-nmpa-300964935。html

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