新基重磅抗癌药Abraxane肺癌适应症获欧盟CHMP支持

来源：生物谷   发布者：王楠   日期：2015-01-28  

生物技术巨头新基（Celgene）在2013年凭借其明星药物Abraxane（注射用紫杉醇[白蛋白结合型]）着实风光了一把，该药是一种化疗药物，因乔布斯之死和癌中之王——胰腺癌适应症而名声大噪。在相关临床试验中，Abraxane已被证明针对多种癌症具有强劲疗效，包括黑色素瘤、膀胱癌、卵巢癌以及乳腺癌、肺癌的。目前，Celgene也正在大力推进相关临床项目及监管申请。就在近日，Abraxane在欧盟监管方面传来了好消息，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已建议批准Abraxane联合卡铂（carboplatin）用于不适合潜在可治愈性手术和/或放射治疗的非小细胞肺癌（NSCLC）成人患者的一线治疗。欧盟委员会（EC）通常都会采纳CHMP的意见，这也意味着Abraxane将在未来几个月内获批用于非小细胞肺癌（NSCLC）适应症。 另一方面，在炎症性疾病领域，Celgene近日顺利拿到欧盟的另一个批文，口服重磅药物Otezla获批用于2种自身免疫性疾病。Otezla是一种首创的口服、选择性磷酸二酯酶4（PDE4）抑制剂，该药是过去20年中获批用于银屑病治疗的首个口服药物，也是过去15年中获批用于银屑病关节炎的首个口服药物。鉴于Otezla相对于市售药物的优势，业界预测，Otezla的年销售峰值将突破20亿美元。（相关阅读：生物技术巨头新基（Celgene）重磅口服药物Otezla拿下欧洲市场） 目前，肺癌是男性和女性中第四种最常见癌症，在欧洲是癌症相关死亡的主要原因。非小细胞肺癌（NSCLC）是肺癌中最常见的形式，约占所有病例的85-90%。当前的治疗方案通常包括全身化疗或蛋白激酶抑制剂。但针对晚期病情，目前唯一能做的通常只能是控制疾病的症状，因此该领域对创新药物存在着明确的医疗需求。 CHMP建议批准的积极意见，是基于一项多中心随机开放标签研究的结果，涉及1052例化疗初治的IIIb/IV非小细胞肺癌(NSCLC)成人患者。研究中，将Abraxane联合卡铂用于晚期NSCLC患者的一线治疗，并与紫杉醇+卡铂组合疗法进行了对比。数据表明，Abraxane+卡铂治疗组总缓解率显著高于紫杉醇+卡铂治疗组（33% vs 25%），达到了研究的主要终点。 目前，Celgene已建立起一支强大的肿瘤学专营权，其中包括一些非常成功的新药。不过，Abraxane一直是该公司的主力产品。Abraxane是紫杉醇的白蛋白结合形式，采用nab专利技术生产。自2013年FDA批准Abraxane胰腺癌适应症之后，该药发展势头迅猛，在2014年第三季度国际销售增长高达62%。去年8月，Celgene与百时美施贵宝签署合作协议，开发PD-1疗法Opdivo（nivolumab）+Abraxane组合疗法，调查用于多种肿瘤的治疗，包括：乳腺癌、胰腺癌、非小细胞肺癌。此次合作，对Celgene而言是一个重要的机会，使Celgene有机会进入数百亿美元的抗癌免疫治疗市场。（生物谷Bioon.com） 英文原文：Celgene's Abraxane wins another OK in Europe CHMP recommends the drug for first-line use against lung cancer Celgene's ($CELG) Abraxane is one of those cancer fighters that has proven effective against many forms of cancer, and so the company has sought approvals far and wide, sometimes successfully and other times not. Now it has been recommended in Europe to treat lung cancer. Already approved in Europe for breast cancer and pancreatic cancer, the New Jersey-based company today reported that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending Abraxane in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. It is the most common form of the disease, accounting for 85% to 90% of cases. In a study comparing it to patients receiving chemo and paclitaxel, the response rate of those taking Abraxane was 33%, compared with 25% in the control arm. "Progress in lung cancer will come first from early diagnosis with patients presenting promptly with symptoms and second, with new drugs that are well tolerated and improve on current therapies. Incremental steps can lead to a meaningful impact on patients and society, given the frequency and aggressiveness of lung cancer," Dr. Mary O'Brien of The Royal Marsden NHS Foundation Trust, U.K., said in the announcement. CHMP's recommendations are generally followed by the European Commission, which generally comes a couple of months later. That will apply to 28 countries. Celgene had a different reception when trying to convince NICE to recommend use of the drug in the U.K. on pancreatic cancer. The hangup there was on price, not effectiveness. Earlier this month the cost watchdog reiterated an earlier finding that the drug was too expensive. Celgene has a host of other cancer drugs, including some very successful new ones, that have generated strong sales. Abraxane, however, has been a workhorse for the drugmaker. In Q3, Celgene said that sales of Abraxane were $212 million, up 25%, with U.S. sales of $151 million and international sales of $61 million. The international number was a 62% leap.

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