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【drug-news】英国国家卫生与临床优化研究所（N
BY JENNIE SMITH 2010-12-22
Elsevier Global Medical News
Breaking News
The clinical effectiveness agency for England and Wales has fast-tracked the anticancer drug bendamustine for use in treating people with chronic lymphocytic leukemia who are unable to tolerate conventional chemotherapy.
The National Institute for Health and Clinical Excellence said Dec. 23 that it had skipped an early step in its guidance drafting process, pushing the drug closer to a recommendation, on the strength of clinical trial evidence showing bendamustine (Levact, Napp) had improved overall survival by more than 13 months, compared with chlorambucil.
Chlorambucil is used for people who cannot tolerate fludarabine combination chemotherapy, the standard first-line treatment for people with Binet stage B or C disease. Bendamustine would be recommended for the same patient group.
Adding to bendamustine’s appeal is its cost, which NICE officials described in a press statement as “low,” though the agency did say how low. The drug, an alkylating agent delivered by intravenous infusion, was developed in East Germany in the 1960s and used mainly in that country until 1990. The recommended dose of bendamustine is 100 mg/m2 intravenously over 30 minutes on days 1 and 2 every 28 days for up to six cycles.
In 2008 the U.S. Food and Drug Administration approved bendamustine for the treatment of CLL and also of B-cell non-Hodgkin lymphoma. In 2010 the European Medicines Agency, in an unusual decision, gave a positive recommendation for the marketing approval of bendamustine that allowed it to be marketed in several countries but not in the European Union as a whole. The decision followed a dispute by some member countries over the drug’s efficacy in some indications.
The drug is now licensed for CLL and non-Hodgkin’s lymphoma, and also for the treatment of multiple myeloma, in Germany, Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain, and the United Kingdom, pending a European Commission decision that would allow the drug to be marketed EU-wide.
In October, NICE officials declined to recommend bendamustine for the treatment of people with low-grade non-Hodgkin lymphoma because, they said, the manufacturer declined to supply the clinical and cost effectiveness data it required to make its decisions.
Around 2,400 people are diagnosed with chronic lymphocytic leukemia in the U.K. each year, NICE said. CLL is the most common form of leukemia in North America and Europe.
Final guidance on bendamustine is expected in 2011, NICE said.
Copyright 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Subjects:
oncology, OncologyEX
英国国家卫生与临床优化研究所（NICE）将推进苯达莫司汀用于治疗慢性淋巴细胞白血病的进程
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英格兰和威尔士的临床疗效评价机构已经快速审批了抗癌药苯达莫司汀用于治疗不能耐受常规化疗的慢性淋巴细胞白血病(CLL)患者这一适应证。
苯达莫司汀是一种烷化剂，经静脉注射给药，于20世纪60年代由东德研制而成，在1990年之前主要在该国家使用。
12月23日，英国国家卫生与临床优化研究所(NICE)表示，NICE现跳过了指南起草过程的早期阶段，离推荐该药更进了一步，因为强有力的临床试验证据表明，与苯丁酸氮芥相比，苯达莫司汀(Levact, Napp)可使患者的总生存期增加13个月以上；另外，苯达莫司汀的治疗费用较低，这也是其一大优势。苯达莫司汀将被推荐用于不能耐受氟达拉滨联合化疗(是Binet分期为B期或C期疾病的标准一线治疗方案)的患者，推荐剂量是100 mg/m2，经静脉注射给药，注射时间不少于30 min，在每个疗程的第1天和第2天给药，28天为1个疗程，持续6个疗程用药。
美国食品药品管理局(FDA)于2008年批准了苯达莫司汀用于治疗CLL和B细胞性非霍奇金淋巴瘤。2010年，欧洲药品管理局断然决定推荐苯达莫司汀在多个国家而非全欧盟上市，此后，一些成员国在该药对某些适应证的疗效方面提出异议。目前该药在德国、奥地利、比利时、丹麦、芬兰、法国、爱尔兰、意大利、卢森堡公国、挪威、波兰、西班牙和英国获准用于CLL、非霍奇金淋巴瘤和多发性骨髓瘤的治疗，而欧洲委员会允许该药在全欧盟上市这一决策仍无定论。NICE官员在10月曾拒绝推荐将苯达莫司汀用于治疗低恶度非霍奇金淋巴瘤，原因为生产厂家拒绝提供相关的临床数据和成本效益数据，而NICE正需要根据这些数据来做出决定。
NICE表示苯达莫司汀的最终指南预计将于2011年出台。
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作者:admin@医学,生命科学 2010-12-27 13:02
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