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[新药快讯] 2014-8-16国内、国际信息汇总

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                           2014-8-16国内、国际信息汇总

1、台资南京诺瑞特医药研发基地在江苏生命科技创新园正式挂牌

                               
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发布日期:2014-08-16  来源:新药汇  


 8月5日上午,由台湾上市公司安成国际药业股份有限公司董事长、国际药学知名博士陈志明先生投资成立的南京诺瑞特医药科技有限公司研发基地在江苏南京市栖霞区江苏生命科技创新园正式挂牌。





                               
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南京诺瑞特医药科技有限公司开幕庆典现场。

该公司主要是研究开发特殊优质长效型新药产品,第一期投资额为450万美元建设研发基地,后续将在宁建设生产基地,用于研发产品产业化生产。

  省台办屠新副巡视员、市台办姜峰副主任和栖霞区统战部时效俊部长等出席了该公司简朴的开业仪式并表示祝贺。在参观完该公司各研发部门及产品研发流程后,省、市、区各部门均希望该公司借助于南京医药研发及生产的人才资源优势,筑牢产品研发基础,生产出优质高效的药品;同时也希望借助于陈志明博士在国际药学界声望,引荐更多优秀的医药研发人才和生产企业到南京落户。



2、FDA批准罗氏安维汀(Avastin)联合化疗治疗晚期宫颈癌

                               
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发布日期:2014-08-16  来源:新药汇


罗氏(Roche)本月喜讯不断,抗癌重磅药物安维汀(Avastin)连续收获2个适应症。8月初,欧盟批准Avastin联合化疗用于铂耐药复发性卵巢癌。8月14日,FDA又批准Avastin联合化疗用于晚期宫颈癌治疗。在《2013全球最畅销药物TOP 10》榜单中,Avastin位列第7,同时也是全球第2畅销肿瘤药,销售额高达67.5亿美元,仅次于罗氏美罗华(Rituxan/MabThera,销售额75亿美元)。


                               
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罗氏8月15日宣布,FDA已批准安维汀(Avastin)联合化疗药物(紫杉醇+顺铂,或紫杉醇+拓扑替康)用于复发或晚期(转移性)宫颈癌患者的治疗。Avastin是2006年拓扑替康和顺铂获批以来,FDA批准用于治疗晚期宫颈癌的首个新药。FDA认为,在当前标准化疗方案基础上联用Avastin有望为晚期宫颈癌患者提供更显著的治疗益处。此前,FDA已授予Avastin补充生物制品许可申请(sBLA)优先审查资格。

本月初,欧盟批准Avastin联合紫杉醇、拓扑替康或聚乙二醇化脂质体阿霉素化疗,用于铂耐药复发性卵巢癌的治疗,使Avastin成为欧盟批准用于铂耐药复发性卵巢癌的首个生物药,也是欧盟铂耐药复发性卵巢癌群体在过去15年中的首个新治疗选择。

Avastin宫颈癌新适应症的获批,是基于大型III期GOG-0240研究的数据。该项研究在452例复发或转移性宫颈癌患者中开展。数据表明,与化疗(紫杉醇+顺铂,或紫杉醇+拓扑替康)相比,Avastin+化疗(紫杉醇+顺铂,或紫杉醇+拓扑替康)显著延长了晚期宫颈癌的总生存期(OS:17个月 vs 13.3个月),达到了研究的主要终点。同时,Avastin+化疗也改善了无进展生存期(PFS:8.2个月 vs 5.9个月),使死亡风险降低29%。

宫颈癌是发生于子宫下部组织子宫颈的癌症,是最常见的妇科恶性肿瘤,近年来其发病有年轻化的趋势。人乳头瘤病毒(HPV)持续感染是宫颈癌的主要危险因素,90%以上的宫颈癌伴有高危型HPV感染。尽管目前已有2种宫颈癌疫苗上市,并能够预防可导致宫颈癌的许多HPV类型,然而,据美国国家癌症研究所(NCI)估计,在美国,2014年将新增1.236万例宫颈癌病例,同时将新增4020例宫颈癌死亡病例。

GOG240是一项独立的、NCI资助的III期临床试验,旨在评估Avastin联合化疗(紫杉醇+顺铂或紫杉醇+拓扑替康)在晚期(IVb期)宫颈癌或经标准治疗后复发的宫颈癌女性患者中的疗效及安全性。该项研究的主要终点是总生存期(OS)。

Avastin目前已在多个国家和地区获批用于结直肠癌、非小细胞肺癌、肾癌、乳腺癌、卵巢癌、神经胶质瘤等多个适应症。

英文原文:FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer

The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.

Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., director of the Office of Hematology and oncology Products in the FDA’s Center for Drug evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”

The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.

The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.

The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.

Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.






3、艾尔健买进膀胱药物Liris对抗Valeant敌意收购

                               
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发布日期:2014-08-16  来源:新药汇


为对抗Valeant和潘兴广场$530亿敌意收购,艾尔健意欲积极扩张,耗资$5.9亿买进膀胱药物Liris。此前,艾尔健已计划投入$100亿专门用于收购。


                               
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为避开加拿大Valeant制药和潘兴广场(Pershing Square)530亿美元的敌意收购,艾尔健(Allergan)近日又有了新动作。日前,艾尔健宣布耗资5.875亿美元从Taris生物技术公司买进一种实验性膀胱药物Liris,该药目前处于II期临床,开发用于间质性膀胱炎(又名膀胱疼痛综合征,BPS)的治疗。Liris的工作原理是通过一个小的植入管,将抗炎药物利多卡因(lidocaine)持续递送至膀胱。该技术源自麻省理工学院。

该笔交易,将用于支持艾尔健泌尿外科研发管线,同时也建立在该公司BOTOX(保妥适)于2013年获批用于膀胱过度活动症(OAB)的成功基础之上。今年1月,在摩根大通医疗大会上,艾尔健CEO David Pyott在接受FierceBiotech采访时表示,将拿出100亿美元专门用于收购。

当然,这是在Valeant制药和潘兴广场提出一系列敌意收购之前的计划,这场持续长达一个月的拉锯战,导致艾尔健不得不对其研发战略进行重新评估。此外,在敌意收购者对其臃肿预算的指责声中,艾尔健已宣布计划裁员1500人,约占员工总数的13%,同时也计划削减对早期研发的投入。

此前,Valeant制药与潘兴广场合作,要求艾尔健召开股东特别大会,意图踢出6位董事会成员,并迫使艾尔健并接受其敌意收购。目前,这场拉锯战仍处于僵局。

至于Taris公司,出售Liris后将使公司能够专注于膀胱癌和膀胱过度活动症(OAB)领域的临床前资产。此外,Taris也正在与阿斯利康(AZN)合作,推进一个单独的膀胱癌项目。

艾尔健以肉毒杆菌药物Botox闻名。根据Valeant,收购艾尔健将在眼科、皮肤科及美学领域缔造无与伦比的产品组合,同时将产生显著的成本及收入协同效应。

英文原文:Allergan bets up to $588M on Taris' bladder candidate

Amid its fight to stave off a hostile takeover, Botox maker Allergan ($AGN) is making a buy of its own, trading up to $587.5 million for a midstage bladder drug from the biotech Taris.

Under the deal, Allergan gets worldwide rights to Liris, a Phase II drug-device combo designed to treat interstitial cystitis, or painful bladder syndrome. The company paid $67.5 million up front and is on the line for another $295 million in development milestones and as much as $225 million tied to commercial performance.

Liris works by continuously delivering the anti-inflammatory drug lidocaine through a small implanted tube feeding directly into the bladder. The technology stems from the labs of MIT's prolific entrepreneurs Michael Cima and Robert Langer, and its promise was enough to sway Polaris Venture Partners, Third Rock Ventures, Flybridge Capital Partners and Flagship Ventures, all of which participated in Taris' $12.5 million E round last year.

For Allergan, the deal bolsters its pipeline in urology and builds off of the company's success in getting Botox approved as a second-line treatment for overactive bladder last year, CEO David Pyott said. The chief executive has long had his eye on expanding Allergan's prospects through M&A, telling FierceBiotech at January's J.P. Morgan Healthcare Conference that he had a $10 billion purse earmarked for takeovers.

Of course, that was before Valeant Pharmaceuticals ($VRX) came calling with a series of hostile offers, sparking a months-long back and forth that has led Allergan to re-evaluate its approach to R&D. Amid its suitor's accusations of bloated budgeting, Allergan has announced plans to cut 13% of its workforce--about 1,500 employees--and curtail its commitment to early-stage research. The two sides remain at an impasse, with Valeant and co-agitator Pershing Square Capital Management working to force a shareholder meeting and get Allergan to take their $48.7 billion offer.

As for Taris, selling off its top prospect will leave the company to focus on its preclinical assets in bladder cancer and overactive bladder, CEO Purnanand Sarma said. The biotech is also working alongside AstraZeneca ($AZN) on a separate bladder cancer program, pursuing multiple candidates under a 2013 agreement.



4、中国医药企业急需大量新药研发人才

                               
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发布日期:2014-08-16  来源:新药汇


国际专业招聘机构瀚纳仕日前发布报告说,中国医药行业需要引进大量研发领域的海归人士和国际人才。

招聘公司最新一期的瀚纳仕季度热点报告显示,临床研究经理、生物统计学经理、生物学专员、区域销售经理以及战略营销经理是生命科学领域需求最高的职位。

据瀚纳仕中国区总监兰熙蒙(Simon Lance)介绍,雇主们除了寻求具备相关经验技能且能适应公司文化的合适人才外,公司仍然为具备适当技能的特殊人才创建新的职位。

瀚纳仕报告称,临床研究仍然是研发中心的核心职能。该领域的经理负责对尚处于开发阶段的新药品进行临床试验,该类人才仍将拥有大量需求。


“另外,生物统计学经理仍拥有大量需求,他们负责管理重要团队,为临床试验提供协助。跨国公司通常希望获得具备国际资格与经验的合适人才。”兰熙蒙称,目前生物学专员拥有市场需求,在发现新的药品混合物方面他们发挥着重要的作用,而新的药品混合物对于产品开发渠道而言非常重要。”

该报告称,中国不只是需要研发人才,具备战略营销技能的市场营销经理也拥有大量需求。另一个趋势是,雇主们力求利用各种资源与平台来推广他们的雇主品牌,吸引更多应聘者。



                               
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新药研发最缺的就是人才


“新药研发最缺的就是人才。”在第49届全国新特药品交易会的现场,天宇长安集团陕西天宇制药有限公司运营总监张宇说道。他认为,医药创新的载体在企业,企业创新的支撑是人才,企业间的竞争实质上就是人才的竞争,而制药企业在新药研发方面最缺乏的,就是人才。

  站在中小企业的角度,以自身企业为例,张宇指出了目前国内药企在新药研发上面临的三大难题:企业规模小,研发投资力度不够;企业中高端研发人才匮乏;企业信息管理系统不够健全。而其中,对新药的研发与创新形成长远阻碍的莫过于人才的持续匮乏。

  和天宇制药如出一辙,当前,国内药企几乎均陷入了人才匮乏的窘境,企业药品研发在加大资金、设备投入的同时,新药研发人才却出现持续断层。

  6、7月份医药研发人才在企业需求基本持平状况下,其人才的供给量却同比下降达50%左右,中高端研发人才呈现持续断层,药品研发人才呈现严重“供不应求”之态。

  “人才短缺,缺的不是个人,而是企业需要的人。”张宇表示。那么,什么样的人才是药企渴求之才?用张宇的解答是一个简单的“T”字。“T”字的一横,代表人才的人际沟通、表达能力以及资源快速整合的能力,“T”字的一竖则代表人才的专业能力、行业深度,天宇长安的“T”字用人需求也正是多数研发创新型药企对人才的关注点。

  药企对人才“专业性、协调性、整合性”等的复合需求,加之研发人才每况愈下的市场供给,无形中加大着创新研发药企的招聘难度。

  如何破解人才断层,助力新药研发?天宇长安的一些尝试或许能与药企引发共鸣:与高等院校、医药院校展开合作,引进、培养后备人才,扩宽人才引进渠道;“以人为本”企业文化营造,让新员工快速融于企业,让老员工在现有岗位高效发挥,完善人才保留机制。实现人才“引进来”与“留下去”的高效资源整合,为新药研发做足支撑。


5、阿斯利康启动哮喘生物药tralokinumab III期项目

                               
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发布日期:2014-08-16  来源:新药汇  


阿斯利康对抗辉瑞1170亿美元收购再添2枚利器,12.6亿美元痛风药lesinurad III期成功,又启动哮喘生物药tralokinumab III期项目,业界预计该市场年销将突破75亿美元。


                               
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近两天,阿斯利康对抗辉瑞1170亿美元收购再添2枚利器。昨日,阿斯利康宣布12.6亿痛风药物lesinurad III期项目获得成功,而今日,阿斯利康又启动哮喘生物药tralokinumab III期临床项目,该项目的启动是基于IIb期研究的喜人结果。目前,数个制药巨头均在竞相开发生物哮喘药,用于对传统吸入性药物反应不佳的严重哮喘群体,业界认为,在未来,生物哮喘药市场每年的销售额将突破75亿美元。

tralokunumab III期临床项目,将调查该药用于严重控制不佳的哮喘(asthma)的治疗。tralokinumab由阿斯利康全球生物制品研发部门MedImmune研发。III期项目的启动,是基于今年5月一项IIb期研究的可喜成果,相关结果已提交至2014年美国胸科学会(ATS)国际会议。

该III期项目将在正接受吸入性糖皮质激素和长效β2激动剂治疗但病情仍未能充分控制的重度哮喘患者中开展,将评估tralokinumab降低哮喘发作频率(AER)的有效性和安全性。此外,该项目还将评估tralokinumab对肺功能、患者报告的哮喘症状和生活质量的影响,同时将探索是否存在潜在的临床生物标志物可帮助确定能够对tralokinumab治疗有响应的患者群体。

tralokinumab是一种实验性人类IgG4单克隆抗体,可强效和选择性中和白细胞介素13(IL-13)。IL-13是一种关键的细胞因子,被认为通过驱动严重、气道过度反应和粘液过多分泌,在严重而频繁的哮喘发作、肺功能受损及其他哮喘症状中发挥重要作用。

此外,阿斯利康症状开展一项II期研究,调查tralokinumab用于轻度至中度特发性肺纤维化(IPF)的治疗。

英文原文:AstraZeneca advances tralokinumab to Phase III in severe asthma

AstraZeneca today announced the start of the Phase III programme for tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by MedImmune, the company’s global biologics research and development arm.

The Phase III programme will evaluate the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations (AER) in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting β2-agonist. The programme will also assess the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, as well as investigate whether potential clinical biomarkers could identify patients who are more likely to respond to tralokinumab.

Tralokinumab is an investigational human monoclonal antibody which potently and selecively neutralises interleukin-13 (IL-13). IL-13 is a key cytokine that is believed to contribute to the onset of severe and frequent asthma attacks, impaired lung function and other debilitating asthma symptoms by driving inflammation, airway hyper-responsiveness and excessive mucus production.

“We are pleased to begin the tralokinumab Phase III programme in severe asthma, further strengthening the breadth of our portfolio in respiratory disease, one of AstraZeneca’s core therapy areas,” said Bill Mezzanotte, Vice President and Head of Inflammation, Neuroscience and Respiratory in AstraZeneca’s Global Medicines Development unit. “Patients with severe asthma currently have limited treatment options and need more effective therapies to control their disease. The development of tralokinumab underscores our commitment to a personalised treatment approach for these patients, to improve their lives. Severe asthma is highly heterogeneous; we are working to better understand patient subtypes, identify potential biomarkers, and tailor therapies to cellular and molecular phenotypes to achieve the best clinical outcomes.”

Initiation of the Phase III programme is based on results from a Phase IIb study conducted by MedImmune. Results from that study were presented at the 2014 American Thoracic Society (ATS) International Conference in San Diego, California in May.

The efficacy and safety of tralokinumab is also being investigated in an ongoing Phase II study in patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) over a 72-week treatment period.

NOTES TO EDITORS

about tralokinumab

Tralokinumab is a human IgG4 monoclonal antibody that targets IL-13, a key cytokine that is believed to play a key role in the pathogenesis of asthma through the promotion of inflammation, airway hyper-responsiveness, mucus hyper-secretion, airway remodeling via fibrosis, increased IgE synthesis and mast cell activation.



6、安进血癌药Kyprolis祸福双至——III期ASPIRE成功 III期FOCUS失败

                               
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发布日期:2014-08-16  来源:新药汇  



                               
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安进(Amgen)及其子公司Onyx制药8月13日公布了血癌药物Kyprolis(carfilzomib)的一项III期FOCUS研究的数据。该项研究是一项开放标签研究,在315例复发性和晚期难治性多发性骨髓瘤(multiple myeloma,MM)患者中开展,将Kyprolis与一种阳性对照方案(低剂量地塞米松或等效皮质类固醇)+可选的环磷酰胺进行了比较。患者既往均过度治疗且平均接受了5种治疗方案。研究中,对照组几乎所有患者均接受环磷酰胺治疗。数据表明,该项研究未能达到改善总生存期(OS)的主要终点。因不良事件导致的停药和死亡在2个治疗组相似。Kyprolis治疗组观察到的心脏事件发生率与Kyprolis药物标签一致。该项研究的相关数据将提交至未来的科学会议。

Onyx公司总裁Pablo J.Cagnoni称,尽管FOCUS研究未能达到总生存期(OS)主要终点,但近期关键III期ASPIRE研究的积极顶线数据已足以支持Kyprolis在各地的监管申请书。

今年8月4日,安进公布了III期ASPIRE研究的既定中期分析数据,该项研究中,Kyprolis联合Revlimid(lenalidomide,来那度胺)及低剂量地塞米松(dexamethasone)组合疗法(KRd)显著改善了无进展生存期(PFS;26.3个月 vs 17.6个月,p<0.0001),达到了研究的主要终点。尽管总生存期(OS)数据尚未成熟,但KRd治疗组已表现出积极的趋势。

在美国,III期ASPIRE研究的数据可能支持将加速批准转变为完全批准,同时扩大Kyprolis当前的适应症。

多发性骨髓瘤(Multiple myeloma,MM)是第二种最常见的血液癌症,是骨髓内浆细胞异常增生的一种恶性肿瘤。由于骨髓中有大量的异常浆细胞增殖,引起溶骨性破坏,又因血清中出现大量的异常单克隆免疫球蛋白,尿中出现本周氏蛋白,引起肾功能的损害,贫血、免疫功能异常。在美国,目前有7万例患者,每年新增2.4万例。在欧洲,约有8.9万例患者,每年新增3.9万例。在全球范围内,有近23万例患者,每年新增11.4万例。

Kyprolis(carfilzomib)注射液于2012年7体液获FDA加速批准,用于既往接受过包括硼替佐米和一种免疫调节剂(IMiD)在内至少2种疗法、但病情在最后一次治疗时或治疗后60天内恶化的多发性骨髓瘤(MM)患者的治疗。该药的获批是基于缓解率。但改善生存及症状等相关临床益处尚未证实。

英文原文:Amgen Announces Top-Line Results From Phase 3 Focus Trial Of Kyprolis® In Patients With Relapsed And Advanced Refractory Multiple Myeloma

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Aug. 13, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and its subsidiary, onyx Pharmaceuticals, Inc., today announced that the Phase 3 clinical trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) did not meet its primary endpoint of improving overall survival (OS) (HR=0.975, 95 percent CI, 0.760, 1.249). The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.

Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rate of cardiac events observed in the Kyprolis arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence  of renal adverse events of all grades observed in the Kyprolis arm compared to the active control arm and the label.

"While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world," said Pablo J. Cagnoni, M.D., president, onyx Pharmaceuticals, Inc.

Detailed results will be submitted for presentation at an upcoming scientific meeting.

about FOCUS
The randomized, open-label Phase 3 FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) trial evaluated single-agent Kyprolis versus an active control regimen of low-dose steroids plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma following treatment with at least three prior therapies. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, overall response rate, clinical benefit rate, duration of response and safety. Patients were randomized to receive Kyprolis (20mg/m2 on days 1 and 2 of cycle 1 followed by 27mg/m2 on days 8, 9, 15, and 16 of cycle 1 and all doses cycle 2 through 9, and 27 mg/m2 on days 1,2,15, and 16 of cycle 10 and beyond) or an active control regimen of oral steroids and optional cyclophosphamide. The trial enrolled 315 patients.

about Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new cases are diagnosed annually.[1] Worldwide, nearly 230,000 people are living with multiple myeloma and approximately 114,000 new cases are diagnosed annually.[2] In Europe, approximately 89,000 people are living with multiple myeloma, and approximately 39,000 new cases are diagnosed annually.[3]

about Kyprolis® (carfilzomib) for Injection
On July 20, 2012, the FDA granted accelerated approval of Kyprolis® (carfilzomib) for Injection for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Kyprolis is marketed in the U.S. by onyx Pharmaceuticals, Inc., an Amgen subsidiary.















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