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罗氏、Exelixis计划向FDA提交治疗黑色素瘤新组合疗法

  1. Exelixis
  2. FDA
  3. 罗氏
  4. 黑色素瘤

来源:生物谷 2014-12-16 11:49

制药巨头罗氏公司和其合作伙伴Exelixis公司最近表示,双方已经向FDA提交其治疗黑色素瘤的联合疗法,FDA已经同意启动加速审批的流程。

2014年12月16日讯 /生物谷BIOON/ --制药巨头罗氏公司和其合作伙伴Exelixis公司最近表示,双方已经向FDA提交其治疗黑色素瘤的联合疗法,FDA已经同意启动加速审批的流程,这一决定将使这一疗法的审批时间由传统的10个月缩短到6个月。这一疗法主要由Exelixis公司开发的cobimetinib和罗氏公司业已上市的Zelboraf组成。此前早些时候,双方已经向欧洲医药管理部门提交了类似的申请。

在最近的一次临床三期研究中,研究人员发现接受cobimetinib和Zelboraf联合治疗的黑色素瘤患者生存期较单独接受Zelboraf治疗的患者明显延长。结果显示,相较于Zelboraf治疗组,联合治疗组患者的无进展生存期(PFS)由6.2个月延长到了9.9个月,达到了研究人员设定的首要终点。

Zelboraf是一种通过作用于黑色素瘤患者BRAF基因V600突变而达到治疗效果的鸡尾酒疗法。Cobimetinib主要作用于MEK激酶。而后者在肿瘤的增殖中起到重要作用。罗氏公司旗下的Genentech公司于2006年以约4000万美元的价格获得了这一药物的授权。双方协议规定,一旦这种联合疗法获得批准,Exelixis公司将与罗氏分享美国市场的收入并获得全球市场的版权收入。

这一消息对Exelixis公司可谓是雪中送炭,此前公司在开发cabozantinib--一种酪氨酸激酶抑制剂药物--治疗前列腺癌的临床研究中遭遇滑铁卢,今年伊始,公司股价甚至重挫80%,同时公司被迫裁员近70%左右。目前公司除了cobimetinib的研究外,尚有cabozantinib治疗肺癌和肝癌的临床研究项目。(生物谷Bioon.com)

详细英文报道:

Partners Roche ($RHHBY) and Exelixis ($EXEL) are making their case to regulators with a melanoma-treating combination therapy, filing an FDA application for the fast-tracked treatment as they await European clearance.

The two are seeking approval for a combination of the Exelixis-discovered cobimetinib and Roche's on-the-market Zelboraf, a cocktail that targets melanomapatients with the V600 mutation in their BRAF genes. Roche's Genentech unit licensed cobimetinib back in 2006, and, if the combo wins approval, Exelixis is entitled to a 50% share of U.S. sales plus royalties on global revenue.

The FDA has granted cobimetinib its fast-track designation, promising to shorten its review time from 10 to 6 months if and when it accepts the application. Roche said it submitted the drug to the European Medicines Agency in September.

In a Phase III study disclosed over the summer, the combination helped subjects live significantly longer without tumor growth than those treated with Zelboraf alone, hitting its primary goal of progression-free survival (PFS). Patients treated with the combination charted a median PFS of 9.9 months compared to 6.2 months on Zelboraf, the companies said.

Cobimetinib's ongoing success is something of a cold comfort for Exelixis, whose long-term fate is more closely tied to the wholly owned cabozantinib. That drug, a tyrosine kinase inhibitor, failed to beat the immunosuppressant prednisone in a Phase III trial in prostate cancer earlier this year, results that sent the biotech's shares plummeting. Exelixis promptly moved to cut about 70% of its workforce, paring down its operation while holding out hope for two ongoing studies testing cabozantinib's effect on kidney and liver cancers.

The latest on cobimetinib had little effect on Exelixis' share price, which is down more than 80% since January.

Exelixis came up with cobimetinib and advanced it to the IND stage before signing on with Genentech, reaping $40 million up front. The drug works by shutting down the kinase MEK, a pathway that regulates growth factor receptors and plays a hand in helping tumors proliferate.

 

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