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安斯泰来抗癌药Xtandi获NICE支持

  1. enzalutamide
  2. Xtandi
  3. 前列腺癌
  4. 安斯泰来

来源:生物谷 2014-07-24 10:39

安斯泰来抗癌药Xtandi获英国NICE支持,用于英国国家卫生服务。该药是一种雄激素受体信号传导抑制剂,旨在干扰睾酮结合前列腺癌细胞的能力,于2012年获FDA批准。

2014年7月24日讯 /生物谷BIOON/ --英国国家健康与临床卓越研究所(NICE)发布指南,支持安斯泰来(Astellas)抗癌药Xtandi(enzalutamide)用于英国国家卫生服务(NHS),用于转移性前列腺癌的治疗。Xtandi在英国的上市之路可谓艰辛,今年早些时候,NICE曾发布指南草案,建议严格限制Xtandi的使用,后经安斯泰来与其他各方努力协商,这些限制最终被推翻。

NICE卫生技术评估中心主任Carole Longson教授表示,支持Xtandi用于NHS,是基于安斯泰来提供给NHS的患者获取方案,其中包括对Xtandi价格的折扣。

关于Xtandi(enzalutamide):

Xtandi是一种新颖的、每日一次的口服雄激素受体信号传导抑制剂,该药能够抑制雄激素受体信号传导通路中的多个步骤,旨在干扰睾酮结合前列腺癌细胞的能力,已被证明能够降低癌细胞的生长,并能诱导肿瘤细胞死亡。睾酮是一种男性激素,能够激化前列腺癌细胞的生长。

Xtandi已于2012年8月获FDA批准用于经激素疗法及化疗后癌症已扩散的男性前列腺癌患者的治疗。(生物谷Bioon.com)

英文原文:NICE backs cancer drugs from Astellas and BMS

Recommendations for Xtandi in prostate cancer and earlier use of Yervoy

The National Institute for Health and Care Excellence (NICE) today backed two new cancer treatments for NHS use in England and Wales.

The guidance recommends a new skin cancer indication for Bristol-Myers Squibb's Yervoy (ipilimumab), while Astellas's Xtandi (enzalutamide) receives its first NICE recommendation for use in prostate cancer.

Yervoy is already recommended for NHS use as a second-line treatment for people with advanced malignant melanoma but this new guidance pushes the drug further up the treatment pathway as a first-line treatment if the tumour cannot be removed or the cancer has spread to other parts of the body.

This means the drug can be made available to cancer patients prior to chemotherapy.

As with the previous NICE guidance for Yervoy, the recommendation is dependent on BMS providing the drug at a discount through a patient access scheme.

Yervoy has performed well for BMS since launching in 2011, with sales of just under $1bn for 2013. Gaining extra indications is crucial for BMS, however, as more advanced rivals in melanoma hit or near the market, including GSK's MEK inhibitor Mekinist (trametinib) and Merck & Co's immunotherapy pembrolizumab.

BMS has its own next generation melanoma treatment in the works in the form of anti-PD1 inhibitor nivolumab. The drug was recently approved in Japan under the name Opdivo.

Xtandi recommended to treat prostate cancer

NICE's second recommendation was for the use of Astellas' Xtandi (enzalutamide) in the treatment of people with prostate cancer that has spread to other parts of the body.

These patients must also have been treated with the cytotoxic drug docetaxel and Astellas must provide Xtandi through a patient access scheme.

The decision follows a troubled path through NICE for Xtandi, which earlier this year was recommended in draft guidance that heavily restricted the use of the drug.

However, following consultation with Astellas and other parties, these restrictions were overturned.

Prof Carole Longson, director of the centre for health technology evaluation at NICE, said: ?°Both cancer treatments are recommended on the basis that the manufacturers provide them to the NHS with a patient access scheme, where there is a discount on the price of the drug.

?°We are also very pleased that the manufacturers have worked with us to provide more evidence so that we are able to recommend both treatments.

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