4月21日，美国FDA批准Cyramza (Ramucirumab)用于治疗晚期胃癌或胃食管交界处腺癌。胃癌形成于胃壁组织，主要影响老年人。根据美国国家癌症研究所提供的信息，美国今年预计会有22220人被确诊患有胃癌，有10990人会死于这种疾病。
Cyramza是一种血管生成抑制剂，它可以阻止向肿瘤供应血液。这款药物适用于癌症不能手术切除（不可切除）或用一种含氟嘧啶或铂类药物治疗后肿瘤已扩散（转移）的患者。
“尽管胃癌在美国的发病率在过去10年已经下降，但患者需要新的治疗选择，特别是在他们对其它治疗药物不再响应时，”FDA药物评价与研究中心血液及肿瘤产品办公室主任、医学博士Richard Pazdur这样称。“Cyramza是一种新的治疗选择，已证明有能力延长患者的生存期，延缓肿瘤的生长。”
Cyramza的安全性及有效性在一项由355名不能切除或转移性胃癌或胃食管交界处腺癌受试者参与的临床试验中得到评价。三分之二的试验受试者接受Cyramza治疗，而剩余受试者接受安慰剂治疗。这项试验旨在检测受试者死亡前的存活期限（总生存期）。
结果显示，以Cyramza治疗的受试者其平均总生存期为5.2个月，相比之下，安慰剂治疗受试者总生存期为3.8个月。此外，Cyramza用药受试者与使用安慰剂的受试者相比，其肿瘤增长得到延缓（无进展生存期）。
第二项临床试验对Cyramza+紫杉醇（另一款癌症药物）与紫杉醇单独用药进行了对比评价，结果也显示Cyramza用药受试者其总生存期得到改善。临床试验期间，Cyramza治疗受试者常见副作用有腹泻和高血压。
FDA对Cyramza的审评是在优先审评程序下完成的，优先审评为那些上市申请提交时，有可能明显改善严重疾病治疗安全性及有效性的药物提供一个加快的审评步骤。Cyramza还被授予了孤儿药资格，因为这款药物旨在治疗一种罕见疾病或症状。Cyramza由位于印地安纳波利斯的礼来上市销售。
商品名：Cyramza 通用名：ramucirumab 中文名：雷莫芦单抗
审批分类：优先审评+孤儿药
药企：Eli Lilly
适应症：化疗失败的胃癌、胃食管连接处腺癌。
剂型规格：本品为10 mg/mL注射液，每2周输液一次，推荐剂量为8 mg/kg。
活性成分：ramucirumab。
作用机理：ramucirumab是一种全人源anti-VEGFR2单抗，阻止VEGF与VEGFR2结合，产生抗血管生成作用。
临床试验：REGARD试验中化疗失败的晚期胃癌、胃食管连接处腺癌患者分成ramucirumab组和安慰剂组，总生存期分别为5.2个月、3.8个月（HR=0.78, P=0.047），无进展生存期分别为2.1个月、1.3个月（HR=0.48, P < 0.001）。
黑框警告：大出血风险，发现出血需要停药。
不良反应：高血压（16% vs 8%）、腹泻（14% vs 9%）、头痛（9% vs 3%）、低钠血症（6% vs 2%）、贫血（3.8%）、肠梗阻（2.1%）。
补充说明：ramucirumab是FDA批准的首个用于胃癌化疗失败后药物，由于大部分胃癌患者在中国（欧美都将胃癌列为罕见病），且该药延长的生存期只有1.4个月，eva1uatePharma预测2018年销售额为6.84亿美元。
另：恒瑞的VEGFR2抑制剂阿帕替尼即将上市，据说已经在修订药品说明书，II期数据报道的无进展生存期为3.67 vs 1.40个月，总生存期为4.83 vs 2.50个月，有效性数据与ramucirumab相当，但副作用似乎比ramucirumab严重得多，如高血压（40%）、手足综合症（25%）、蛋白尿（27%）、转氨酶升高（19%）、白细胞减少（49%）、血小板减少（30%）、嗜中性白血球减少（38%）、贫血（19%），可谓肝毒性、肾毒性、血液毒性齐全，个人对阿帕替尼的年销售额预期是5亿人民币。
FDA approves Cyramza for stomach cancer
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
Stomach cancer forms in the tissues lining the stomach and mostly affects older adults. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year.
Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (me-tastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.
“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug eva1uation and Research. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”
Cyramza’s safety and effectiveness were eva1uated in a clinical trial of 355 participants with unresectable or me-tastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. The trial was designed to measure the length of time participants lived before death (overall survival).
Results showed participants treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who took Cyramza experienced a delay in tumor growth (progression-free survival) compared to participants who were given placebo. Results from a second clinical trial that eva1uated the efficacy of Cyramza plus paclitaxel (another cancer drug) versus paclitaxel alone also showed an improvement in overall survival.
Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high blood pressure.
The FDA reviewed Cyramza under its priority review program, which provides an expedited review for drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.
Cyramza is marketed by Indianapolis-based Eli Lilly.
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