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FDA授予礼来单抗药ramucirumab优先审查资格

来源:生物谷 2013-10-25 07:13

2013年10月25日讯 /生物谷BIOON/ --礼来(Eli Lilly)10月23日宣布,FDA已授予ramucirumab生物制剂许可申请(BLA)优先审查资格,该药开发作为一种单药疗法,用于初始化疗后病情恶化的晚期胃癌患者的治疗。

ramucirumab BLA的提交,基于一项全球性、随机、双盲III期研究REGARD的数据。该项研究在初始化疗后病情恶化的晚期胃癌患者中开展,将ramucirumab+最佳支持治疗与安慰剂+最佳支持治疗进行了对比。

今年9月,有关ramucirumab的另一项III期胃癌研究RAINBOW取得成功。RAINBOW是一项全球性、随机、双盲III期试验,在初始化疗后病情恶化的晚期(局部晚期、不可切除性或转移性)胃癌(gastric cancer)患者中开展,将ramucirumab+紫杉醇(paclitaxel)组合疗法与安慰剂+紫杉醇进行了对比,该项研究达到了改善总生存期(OS)的主要终点,同时也达到了改善无进展生存期(PFS)的次要终点。

目前,礼来正在开展其他相关III期研究,在大肠癌、肝癌、肺癌中评价ramucirumab,这些研究的数据预计将于2014年获得。

关于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、肺癌已处于III期临床开发。(生物谷bioon.com)

英文原文:FDA Grants Lilly's Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer

INDIANAPOLIS, Oct. 23, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

"We are very pleased that the FDA has granted Priority Review to ramucirumab in advanced gastric cancer, as patients with this difficult-to-treat disease typically have a poor prognosis and limited treatment options," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "If approved, ramucirumab will be the first FDA-approved therapy for patients in this setting. Overall, stomach cancer is the second leading cause of cancer death globally and remains an area of high unmet need."

Priority Review status for a biologics license application, or BLA, means that the FDA's goal is to take action within eight months of a completed filing. Therefore, Lilly anticipates agency action on this application in the second quarter of 2014. The priority designation aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment.

This BLA for ramucirumab was based on data from REGARD, a global, randomized, double-blind Phase III study of ramucirumab plus best supportive care compared to placebo plus best supportive care as a treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastro-esophageal junction) following progression after initial chemotherapy. A registration dossier is also under regulatory review by the European Medicines Agency (EMA) for a Marketing Authorization Application.

Lilly also studied ramucirumab in combination with paclitaxel for the treatment of advanced gastric cancer in its Phase III RAINBOW trial. The combination-therapy ramucirumab data from that trial will be the basis for separate regulatory applications. Lilly expects top-line results from three additional Phase III trials of ramucirumab - one each in colorectal, hepatocellular (liver) and lung cancer - in 2014.

About Ramucirumab
Ramucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.

Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as a single agent and in combination with other anticancer therapies for the treatment of multiple types of cancer. Beyond gastric cancer, results from three Phase III trials - one each in colorectal, hepatocellular (liver) and lung cancer - are expected in 2014.

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