礼来（Eli Lilly）肿瘤学管线近日传来好消息。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成人患者的治疗。
这是Cyramza在欧洲的首个监管申请。EMA通常都会采纳CHMP的意见，预计EMA将在3个月内批准Cyram上市。
此前，Cyramza已于今年4月获FDA批准，用于不能手术切除（不可切除性）或经化疗后扩散（转移）的晚期胃癌和胃食管交界部腺癌（GEJA）患者的治疗。
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，分析师预测，Cyramza在2019年的年销售额将达到10亿美元。
CHMP的积极意见，是基于2项全球性、随机、双盲、安慰剂对照III期研究RAINBOW和REGARD的数据。RAINBOW研究评估了Cyramza联合紫杉醇化疗，用于既往经化疗治疗的晚期胃癌或GEJA成人患者的治疗。REGARD研究评估了Cyramza作为单药疗法，用于相同适应症的治疗。此前，欧盟委员会（EC）已授予Cyramza治疗胃癌的孤儿药地位。
在美国，Cyramza于今年4月获FDA批准，用于晚期或转移性胃癌和胃食管交界腺癌（GEJA）成人患者的治疗。礼来计划于2015年上半年向FDA提交Cyramza/紫杉醇组合疗法治疗结直肠癌的上市申请。
Cyramza是一种全人源化IgG1单克隆抗体，该药是一种受体拮抗剂，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。
Cyramza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。
英文原文：COMUNICADO: CHMP Recommends Approval of Lilly's Ramucirumab (CYRAMZA(TM)) for Advanced Gastric Cancer After Prior Chemotherapy (1)
Positive Opinion Is First Regulatory Action for Ramucirumab in the EU
INDIANAPOLIS, Sept. 26, 2014 /PRNewswire/ -- Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ramucirumab (CYRAMZA(TM)), in adults, in combination with paclitaxel, for the treatment of advanced gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.
"Gastric cancer is a devastating and difficult-to-treat disease. Today's news brings us one step closer to providing an important new treatment option in the EU for people with this disease that has progressed on or after prior chemotherapy," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "If approved, ramucirumab would be the first therapy approved in the EU specifically indicated for second-line gastric cancer."
This is the first regulatory action for ramucirumab in Europe in any indication. Following a CHMP positive opinion, the European Commission generally follows the recommendation and usually issues its final decision on marketing authorization within three months.
This CHMP opinion is based on results from two global, randomized, double-blind and placebo-controlled Phase III studies: RAINBOW and REGARD. RAINBOW evaluated ramucirumab in combination with paclitaxel (a type of chemotherapy) for advanced gastric or GEJ adenocarcinoma after prior chemotherapy while REGARD evaluated ramucirumab as a single agent in the same setting. Specifically, this opinion would potentially make ramucirumab available for adults in combination with paclitaxel, for the treatment of advanced gastric or GEJ adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.
Ramucirumab has been granted Orphan Drug Designation by the European Commission for treatment of gastric cancer in the EU. Orphan drug status is given to medicines that have demonstrated promise for the treatment of rare diseases.
In the United States, ramucirumab received U.S. Food and Drug Administration approval in April as a single agent for the treatment of advanced or metastatic gastric or GEJ adenocarcinoma following prior chemotherapy. Lilly expects FDA action on its submission for ramucirumab in combination with paclitaxel, in this setting, in the first half of 2015.
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