2014年12月24日讯 /生物谷BIOON/ --导读：2014年是礼来最为艰难的一年，数个畅销药遭仿制药重创。而肿瘤学管线中抗癌药Cyramza在今年的表现堪称完美，截至目前已收获FDA 3个批文，并于近日收获欧盟首个批文。业界预测，Cyramza的年销售峰值将突破15亿美元，该药在美欧市场的持续走强，将帮助缓解仿制药冲击导致的销售损失。
礼来（Eli Lilly）近日宣布，欧盟委员会（EC）已批准单抗药物Cyramza（ramucirumab）：（1）联合紫杉醇（paclitaxel），用于既往经化疗治疗的晚期胃癌或胃食管交界腺癌（GEJA）成人患者的治疗；（2）作为一种单药疗法，用于不适合紫杉醇联合疗法的晚期胃癌或胃食管交界腺癌（GEJA）成人患者的治疗。
Cyramza是欧盟批准的首个胃癌二线治疗药物，标志着欧盟胃癌患者临床治疗的一个重大里程碑。胃癌也是Cyramza在欧盟获批的首个适应症，该药的获批，是基于2项大型III期研究（RAINBOW和REGARD）的数据，研究中Cyramza作为单药疗法或联合紫杉醇的组合疗法均显著改善了总生存期（OS）和无进展生存期（PFS）。此前，欧洲药品管理局（EMA）孤儿药产品委员会（COMP）已授予Cyramza治疗胃癌的孤儿药地位。
在美国，截至目前Cyramza已收获FDA 3个批文。本月中旬，FDA已批准Cyramza联合多西他赛（docetaxel，一种化疗药物）用于既往经含铂化疗治疗失败的转移性非小细胞肺癌（NSCLC）患者的治疗。此前，FDA已于今年4月和11月批准Cyramza及Cyramza+紫杉醇化疗联合疗法，用于晚期或转移性胃癌和胃食管交界腺癌（GEJA）的治疗。另外，礼来已计划于2015年上半年向FDA提交Cyramza+紫杉醇联合疗法治疗结直肠癌的上市申请，在III期临床中，该组合疗法显著改善了总生存期（OS）。
Cyramza是一种血管生成抑制剂，能够阻断肿瘤的血液供应，该药被认为是礼来研发管线中最重要的产品之一。不过，Cyramza的临床项目并不都是一帆风顺，去年秋天，Cyramza在乳腺癌III期临床中以失败告终，未能改善无进展生存期（PFS）。
关于Cyramza（ramucirumab）：
ramucirumab是一种全人源化IgG1单克隆抗体，是一种受体拮抗剂，靶向结合于血管内皮生长因子（VEGF）受体2的胞外域，从而阻断血管内皮生长因子配体（VEGF-A，-C，-D）的相互作用，并抑制受体激活。
Ramucirumab由礼来于2008年耗资65亿美元收购ImClone公司后获得，目前正在开展相关临床试验，评估该药作为单药疗法及与其他抗癌药物的联合疗法，用于治疗乳腺癌、胃癌、非小细胞肺癌、大肠癌、肝癌、膀胱癌、尿道癌、输尿管癌、肾盂癌、前列腺癌、卵巢癌、多形性成胶质细胞瘤。目前乳腺癌、大肠癌、胃癌、肝癌、肺癌均处于III期临床开发。（生物谷Bioon.com）
英文原文：Lilly’s Cyramza approved in EU for stomach cancer
The European Commission has granted marketing authorisation (MA) for Eli Lilly's ramucirumab (Cyramza) in stomach cancer, making it the first therapy approved for second-line advanced stomach and gastro-oesophageal junction (GOJ) cancer in the region.
The approval follows a similar ruling by the US Food and Drug Administration (FDA) in November, allowing Cyramza to be given with paclitaxel, and helps reinforce Lilly's position as a leader in oncology.
The FDA also gave the green light earlier this month for its use in non-small cell lung cancer (NSCLC) and Lilly hopes it will be approved early next year for metastatic colorectal cancer, based on phase III studies showing improved overall survival rates. It has been tipped as a top prospect for the company – predicted to generate sales of over $1.5 billion a year at its peak.
It is the first licensed therapy specifically indicated for adult patients with advanced gastric or GOJ adenocarcinoma, following prior chemotherapy (fluoropyrimidine and platinum). Ramucirumab is approved in combination with paclitaxel chemotherapy and as a single agent in patients for whom treatment with paclitaxel is not appropriate.
The approval is based on two international phase III studies, showing it extended overall survival time and delayed disease progression versus each study comparator.
"Unfortunately, most patients with gastric cancer face a poor prognosis. Around 80 per cent are first diagnosed once their cancer has spread and become difficult to treat. Despite research efforts, there have been few advances in the last 30 years and inoperable gastric cancer remains a devastating disease. Ramucirumab provides a welcome new treatment option for these patients," said Prof David Ferry, global senior medical director at Lilly.
The phase III study programme involved 1,020 patients from 289 cancer centres and showed that ramucirumab, combined with paclitaxel, significantly extended overall survival time to 9.6 months compared with 7.4 months for placebo plus paclitaxel.
As a single agent, ramucirumab extended overall survival time to 5.2 months compared with 3.8 months for best supportive care.
"Today marks an important milestone for patients with this difficult-to-treat disease," said Dr Richard Gaynor, SVP of product development and medical affairs at Lilly Oncology. "Ramucirumab is an innovative therapy that specifically binds to and blocks vascular endothelial growth factor (VEGF) Receptor 2 - a key mediator of VEGF-induced angiogenesis, which feeds cancer growth."
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended a further seven drugs for MA this month, including Holoclar, Mysimba, Xadago, Xydalba, Quinsair, Tasermity and Clopidogrel ratiopharm, which brings the total for the year to over 80.