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首页 » FDA信息 » FDA批准礼来单抗Cyramza第3个适应症:非小细胞肺癌

FDA批准礼来单抗Cyramza第3个适应症:非小细胞肺癌

来源:生物谷 2014-12-18 20:05

2014年12月18日讯 /生物谷BIOON/ --导读:2014年是礼来最为艰难的一年,数个畅销药因专利悬崖导致销售大幅下跌。而肿瘤学管线中,抗癌药物Cyramza接连拿下3个适应症,对礼来而言无疑是个大好消息。分析师预计,到2020年,Cyramza的年销售额将达到13.5亿美元,该药在临床中的成功将部分弥补仿制药冲击导致的销售损失。

近日,礼来(Eli Lilly)肿瘤学管线近日传来大好消息,抗癌药物Cyramza(ramucirumab)收获了FDA的第3个适应症。具体而言,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后病情恶化的转移性非小细胞肺癌(NSCLC)患者的治疗。此前,FDA已分别于今年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/紫杉醇组合疗法治疗结直肠癌的上市申请。

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,未能达到改善无进展生存期(PFS)的主要终点。

Cyramza非小细胞肺癌(NSCLC)适应症的获批,是基于III期REVEL研究的数据。该项研究调查了Cyramza联合化疗用于非小细胞肺癌(NSCLC)的二线治疗。数据表明,与安慰剂+多西他赛化疗相比,Cyramza+多西他赛化疗显著改善了总生存期(OS:10.5个月 vs 9.1个月,p=0.023;死亡风险降低14%)、显著改善了无进展生存期(PFS:4.5个月 vs 3.0个月,p<0.001;疾病恶化风险降低24%)、显著改善了客观缓解率(ORR:23% vs 14%,p<0.0001)。该研究是首个证明一种生物制剂联合化疗用于二线治疗时可改善NSCLC总生存期的III期研究。

在美国,肺癌是癌症致死的首要病因,其中非小细胞肺癌(NSCLC)占到了总病例的85%。据估计,约有一半的NSCLC患者正接受二线治疗。尽管目前有可用的药物,但仍需要新的二线治疗药物。

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 blockbuster hopeful Cyramza nabs key new use in lung cancer

The plan for Eli Lilly's ($LLY) Cyramza has always been to rack up a string of approvals to vault the drug into blockbuster territory. As of Friday, the Indianapolis drugmaker is one step closer to achieving that goal.

The FDA has green-lighted the cancer-fighter in combination with chemo drug docetaxel as a treatment for non-small cell lung cancer, a malady the National Cancer Institute estimates will afflict 224,210 new patients in the U.S. this year. It's the third indication Cyramza has snagged in 2014, following agency approvals in advanced stomach cancer and advanced gastric cancer.

"The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients," the Center for Drug Evaluation and Research's Richard Pazdur said in a statement.

It could also yield an important revenue bump for Eli Lilly, which is facing a hefty sales decline in the wake of patent expirations on top sellers Cymbalta and Evista. The company has predicted this year could be its worse yet, and third-quarter numbers seemed to support that forecast. Net income plunged 58% to $501 million from last year's $1.02 billion, with Cymbalta sales diving 73% and Evista sales dropping by 65%.

The lung cancer go-ahead could help Cyramza sales reach $1.35 billion in 2020, JPMorgan analyst Chris Schott told investors in September. A second-line colorectal cancer nod--which looks possible after a recent study of 1,000 patients turned out positive survival data--could boost Cyramza's top-line firepower, too.

It hasn't been all smooth sailing for Cyramza, however. Last fall, the drug flopped in a late-stage breast cancer trial, failing to hit its primary endpoint for progression-free survival.

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