NICE支持罗氏的Alecensa

2018-06-28 MedSci MedSci原创

罗氏公司的Alecensa作为一种治疗罕见肺癌的药物获得了良好的支持,推翻了之前拒绝为该药物提供NHS资金的决定。在指南草案中,该机构在其市场许可的范围内,批准该药物作为未经治疗的再生性淋巴瘤激酶(ALK)阳性晚期非小细胞肺癌(NSCLC)的一种选择,在英国大约有925人感染该药物。"这对临床医生和患者来说是个好消息,"肿瘤医学顾问医师Riyaz Shah博士评论这一决定时说。"ALK阳性非小细胞

罗氏公司的Alecensa作为一种治疗罕见肺癌的药物获得了良好的支持,推翻了之前拒绝为该药物提供NHS资金的决定。

在指南草案中,该机构在其市场许可的范围内,批准该药物作为未经治疗的再生性淋巴瘤激酶(ALK)阳性晚期非小细胞肺癌(NSCLC)的一种选择,在英国大约有925人感染该药物。

"这对临床医生和患者来说是个好消息,"肿瘤医学顾问医师Riyaz Shah博士评论这一决定时说。
"ALK阳性非小细胞肺癌是一种罕见的肺癌,主要影响年轻人,非吸烟者,并且有向大脑扩散的倾向。


"Alectinib在延缓这些患者癌症生长方面已经有了显著的改善。它在预防和延缓癌症扩散到大脑中也显示出显著的改善。"

NICE表示,这项建议是一项正在进行的临床试验的结果,显示Alecensa(alectinib)在延缓疾病进展方面更有效,比目前的crizotinib标准治疗延长了约15个月。

该委员会得出结论认为,对于未经治疗的ALK阳性晚期非小细胞肺癌患者,Alecensa与克唑替尼相比最合理的仪器成本效益估计(ICER)为每增加QALY 20,000至30,000英镑。

但是,NICE的建议还取决于罗氏是否按照患者接入计划中商定的商业折扣提供药物。

去年12月,Alecensa在欧洲获得批准,第三阶段数据显示,给予该药物的患者的中位无进展生存期为25.7个月,而服用当前标准治疗的患者为10.4个月。

研究结果还显示,与克唑替尼相比,Alecensa减少了肿瘤向脑内或中枢神经系统(CNS)传播或增长的风险达84%。约60%的患者会在中枢神经系统发生转移。

在获得批准之前,罗氏通过英国的早期药品计划(EAMS)向Alecensa提供该药品,允许患者在获得正式批准前获得具有未满足的临床需求的有前途的新型未经许可的药品。

英国罗氏公司癌症免疫治疗负责人西蒙·埃尔斯说:"我们很高兴这种罕见肺癌患者能够通过英国国家医疗服务系统获得阿列替尼。"


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    2018-07-31 kksonne
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    2018-06-30 fusion
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    2018-06-28 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

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    2018-06-28 三生有幸9135

    学习一下

    0

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    2018-06-28 329523732

    不错

    0

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