2014年12月9日讯/生物谷BIOON/--近日，英国批准了罗氏的Gazyvaro (obinutuzumab)在英国国民医疗保健体系(NHS)中使用，这意味着从现在起，苏格兰地区的慢性淋巴细胞白血病（CLL）患者可以通过正规途径获得该药品进行治疗。
Gazyvaro是首款用于治疗CLL的“2型”抗CD20单克隆抗体，超越MabThera (rituximab)之类的“1型”药物疗效。据罗氏介绍，Gazyvaro治疗CLL采取的是“双管齐下”的途径，一方面是直接杀灭癌细胞，另一方面是改善人体免疫系统抵抗癌细胞的能力，提高人体免疫力。
此外，Gazyvaro被Sottish Medicines Consortium推荐与苯丁酸氮芥化疗联合使用治疗早期CLL，以及那些同时不适合全剂量氟达拉滨治疗的患者。
苏格兰的临床研究数据有力地支撑了这一观点，数据显示Gazyvaro联合化疗减少了59%的死亡率；和单一化疗相比无进展生存期延长到15个月，并且与未施加以上治疗的对照组相比，患者的完全缓解率达到了22.3%。
在安全性方面，罗氏表示患者对Gazyvaro的耐受性很好，大部分常见的不良反与输液相关，其中21%的患者输液不良反应较为严重。其他见报告的不良反应是嗜中性白细胞减少症（35%）、血小板减少(11%)、感染（11%）、贫血（5%）和白细胞减少症（5%）。
关于Gazyvaro（obinutuzumab）
obinutuzumab在美国的商品名为Gazyva，已获FDA批准，联合苯丁酸氮芥（chlorambucil）化疗，用于既往未经治疗的慢性淋巴细胞白血病（CLL）患者。Gazyva的获批，将减少生物仿制药对罗氏重磅药物美罗华（Rituxan，通用名：rituximab，利妥昔单抗）的冲击。
obinutuzumab又名GA101，是首个糖基化的II型抗CD20单克隆抗体，靶向B细胞表面的CD20分子，能够直接诱导B细胞死亡。obinutuzumab旨在增强抗体依赖性细胞毒性作用（Antibody-Dependent Cellular Cytotoxicity，ADCC）及直接的细胞死亡诱导作用（Direct Cell Death induction）。
原文 Scottish patients get access to Roche's CLL drug on NHS
From today patients in Scotland with chronic lymphocytic leukaemia (CLL) have gained ‘routine’ access to a new treatment option after cost-regulators approved Roche’s Gazyvaro (obinutuzumab) for National Health Service use in the country.
Gazyvaro is the first ‘type II’ anti-CD20 monoclonal antibody licensed for the treatment of CLL and is designed to attack blood cancers more aggressively than ‘type I’ treatments such as MabThera (rituximab).
According to the Swiss drugmaker， the drug has a double-pronged mode of attack being able to kill cancer cells directly as well as alert the body’s immune system to ‘enemy’ cancer cells， thereby boosting the immune response.
Specifically， Gazyvaro has been recommended by the Sottish Medicines Consortium for use in combination with chlorambucil chemotherapy for the treatment of previously-untreated patients with CLL and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy.
Clinical data from a key study， conducted in Scotland， helped secure the decision， showing that Gazyvaro/chemotherapy cut the risk of death by 59% and boosted progression-free survival by 15 months versus chemo alone， while 22.3% of patients were in complete remission compared to none of those in the control arm.
On the safety side， Roche says the drug has a “manageable tolerability profile” with the most common adverse events being infusion-related reactions， 21% of which were severe. Others reported were neutropenia (35%)， low platelet count (thrombocytopenia) (11%)， infections (11%)， anaemia (5%) and leukopenia (5%).
The SMC decision closely follows a National Institute for Health and Care Excellence draft guidelines recommending use of Gazyvaro on the NHS in England.