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开年大吉,罗氏、Exelixis黑色素瘤药物距获批仅一步之遥

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

来源:生物谷 2015-02-22 18:49

羊年刚过,FDA就发给了罗氏和其合作者Exelixis公司一个"大红包"!

2015年2月22日讯 /生物谷BIOON/-- 所谓行百里者半九十。审批过程对于所有上市药品来说都是最重要的一个环节。不过,严苛的FDA对某些药物则显得青睐有加。这不,羊年刚过,FDA就发给了罗氏和其合作者Exelixis公司一个"大红包"!FDA已经接受了两家公司提交的治疗黑色素瘤联合疗法上市申请,并表示将对这种疗法启动加速审批的待遇。此次罗氏公司和Exelixis公司开发的这种鸡尾酒疗法结合了Exelixis公司的新药cobimetinib和罗氏公司已上市的黑色素瘤药物Zelboraf,而后者此前已经被FDA批准用于治疗BRAF基因V600突变引起的黑色素瘤。罗氏旗下的Genentech公司在2006年就获得了cobimetinib的授权。作为回报,一旦这种联合疗法上市,Exelixis公司将获得美国市场50%的份额并分享全球市场版权。Cobimetinib是一种调节MEK激酶的药物,而MEK激酶的主要功能是调节生长因子受体相关通路,这一通路在肿瘤的发生发展中起着重要作用。

此次FDA同意对该疗法采用加速审批政策无疑大大缩短了这种药物上市所需要的时间。FDA预计将于今年的8月11日之前作出最终决定。与此同时,两家公司也并未闲着,而是双管齐下,同时进行欧洲市场的申请事宜。根据此次两家公司提供的临床数据显示,与单独使用Zelboraf相比,cobimetinib与Zelboraf联合治疗能够将患者的无进展生存期由单独使用的6.2个月延长至9.9个月。此次,FDA受理两家公司的药物申请无疑使这种药物疗法距离登陆市场更进一步。(生物谷Bioon.com)

详细英文报道:

Roche ($RHHBY) and Exelixis ($EXEL) are one step closer to FDA approval for their skin cancer-treating combination treatment, as the agency has accepted their application and promised a speedy review.

The companies are seeking approval for a combination of the Exelixis-discovered cobimetinib and Roche's on-the-market Zelboraf, a cocktail that targets melanoma patients 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 agency has granted the combination its priority review status, cutting four months off of its standard timeline and promising to hand in a final decision by Aug. 11. Roche and Exelixis are also awaiting European approval after filing an application in September.

Each filing is based on Phase III data in which the combination helped subjects live significantly longer without tumor growth than those treated with Zelboraf alone, hitting the 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.

"The FDA's acceptance of the cobimetinib NDA brings us one step closer to a potential new treatment option for patients with advanced BRAF V600 mutation-positive melanoma, a form of the disease for which new approaches are needed," Exelixis CEO Michael Morrissey said in a statement.

The news sent Exelixis' shares up nearly 10% in premarket trading on Thursday, but pervasive setbacks with the biotech's wholly owned pipeline have marred investor confidence. The company's lead asset, cabozantinib, failed to beat the immunosuppressant prednisone in a Phase III trial in prostate cancer last 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.

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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