2014年12月9日訊/生物谷BIOON/--近日，英國批准了羅氏的Gazyvaro (obinutuzumab)在英國國民醫療保健體系(NHS)中使用，這意味著從現在起，蘇格蘭地區的慢性淋巴細胞白血病（CLL）患者可以通過正規途徑獲得該藥品進行治療。
Gazyvaro是首款用於治療CLL的「2型」抗CD20單克隆抗體，超越MabThera (rituximab)之類的「1型」藥物療效。據羅氏介紹，Gazyvaro治療CLL採取的是「雙管齊下」的途徑，一方面是直接殺滅癌細胞，另一方面是改善人體免疫系統抵抗癌細胞的能力，提高人體免疫力。
此外，Gazyvaro被Sottish Medicines Consortium推薦與苯丁酸氮芥化療聯合使用治療早期CLL，以及那些同時不適合全劑量氟達拉濱治療的患者。
蘇格蘭的臨床研究數據有力地支撐了這一觀點，數據顯示Gazyvaro聯合化療減少了59%的死亡率；和單一化療相比無進展生存期延長到15個月，並且與未施加以上治療的對照組相比，患者的完全緩解率達到了22.3%。
在安全性方面，羅氏表示患者對Gazyvaro的耐受性很好，大部分常見的不良反與輸液相關，其中21%的患者輸液不良反應較為嚴重。其他見報告的不良反應是嗜中性白細胞減少症（35%）、血小板減少(11%)、感染（11%）、貧血（5%）和白細胞減少症（5%）。
關於Gazyvaro（obinutuzumab）
obinutuzumab在美國的商品名為Gazyva，已獲FDA批准，聯合苯丁酸氮芥（chlorambucil）化療，用於既往未經治療的慢性淋巴細胞白血病（CLL）患者。Gazyva的獲批，將減少生物仿製藥對羅氏重磅藥物美羅華（Rituxan，通用名：rituximab，利妥昔單抗）的衝擊。
obinutuzumab又名GA101，是首個糖基化的II型抗CD20單克隆抗體，靶向B細胞表面的CD20分子，能夠直接誘導B細胞死亡。obinutuzumab旨在增強抗體依賴性細胞毒性作用（Antibody-Dependent Cellular Cytotoxicity，ADCC）及直接的細胞死亡誘導作用（Direct Cell Death induction）。(生物谷Bioon.com)
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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.