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失而复得,罗氏白血病药物Gazyvaro重获NICE批准

2014-12-04 佚名 生物谷

英国国家健康与临床卓越研究所 (NICE)近日撤回了对罗氏白血病药物Gazyvaro的限制,目前Gazyvaro仍处于英格兰和威尔士的NHS批准过程中,尽管如此,这对于罗氏而言无疑是一个好消息。 NICE近日发布了新规定,同意Gazyvaro(obinutuzumab)用于治疗慢性淋巴细胞白血病患者。就在两个月前,NICE认为罗氏提交的相关数据质量的问题,拒绝该药通过。 作为肿瘤药市场的领

英国国家健康与临床卓越研究所 (NICE)近日撤回了对罗氏白血病药物Gazyvaro的限制,目前Gazyvaro仍处于英格兰和威尔士的NHS批准过程中,尽管如此,这对于罗氏而言无疑是一个好消息。

NICE近日发布了新规定,同意Gazyvaro(obinutuzumab)用于治疗慢性淋巴细胞白血病患者。就在两个月前,NICE认为罗氏提交的相关数据质量的问题,拒绝该药通过。

作为肿瘤药市场的领跑者,罗氏当然不会善罢甘休,随即提交了药物有效性的相关修正数据,并且为患者提供获取药物的折扣,希望能借此让NICE回心转意。相关负责Carole Longson认为,罗氏积极响应了NICE的意见,并且很快提供了进一步的数据,这为NICE批准Gazyvaro治疗慢性淋巴细胞白血病提供了可能。Carole Longson解释说,既然半数慢性淋巴细胞白血病(CLL)患者无法使用某些一线化疗药物(如氟达拉滨),并且对Astellas的替代品Levact(苯达莫司汀)也不敏感,那么Gazyvaro也不失为一种选择。Obinutuzumab临床有效,并且不良反应更少,能够有效地阻止病情恶化。

罗氏对NICE的新指南当然是欢欣鼓舞,英国区总管Jayson Dallas高兴地表示,NICE重新同意Gazyvaro的使用,对于提高CLL患者的生存率具有重要意义,目前当务之急是要把NICE的批准草案转化成最终的用药指南,以便患者能尽快用药治疗。

今年6月Gazyvaro获得了欧洲批准,2013年11月,该药物以Gazyva的药品名获得FDA批准。目前NICE的指南将于2015年1月6号被提交审议,随后最新草案将会颁布。

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    2014-12-06 fusion
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    2014-12-06 cy0326

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