打开APP

CHMP建议批准GSK单抗药Arzerra用于慢性淋巴细胞白血病的治疗

  1. Arzerra
  2. B细胞
  3. CD20分子
  4. ofatumumab
  5. 单抗
  6. 慢性淋巴细胞白血病
  7. 葛兰素史克

来源:生物谷 2014-05-25 09:45

欧盟CHMP建议批准葛兰素史克Arzerra用于慢性淋巴细胞白血病的治疗。该药是一种单克隆抗体,靶向B细胞表面的CD20分子,于2014年4月获FDA批准。

2014年5月25日讯 /生物谷BIOON/ --葛兰素史克(GSK)5月23日宣布,单抗药物Arzerra(ofatumumab)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Arzerra联合苯丁酸氮芥(chlorambucil)或苯达莫司汀(bendamustine),用于初治及不适合氟达拉滨(fludarabine)化疗的慢性淋巴细胞白血病(CLL)患者的治疗。

CHMP的积极意见,是基于在不适合氟达拉滨化疗方案的初治CLL患者中开展的2项临床试验的数据。

OMB110911(COMPLEMENT1)是一项随机、开放标签、平行组、多中心、关键III期研究,在超过400例初治CLL患者中开展,研究中将ofatumumab+苯丁酸氮芥(chlorambucil)组合疗法与苯丁酸氮芥单药疗法进行了对比。数据表明,与苯丁酸氮芥单药疗法相比,组合疗法显著改善了疾病无进展生存期(PFS,22.4个月 vs 13.1个月,p<0.001)。OMB115991是一项单组、多中心II期研究,评估了ofatumumab+苯达莫司汀组合疗法的疗效。

此前,Arzerra已于2014年4月获FDA批准,联合苯丁酸氮芥(chlorambucil)用于初治且不适和氟达拉滨(fludarabine)化疗的慢性淋巴细胞白血病(CLL)患者的一线治疗。Arzerra由葛兰素史克(GSK)和Genmab联合开发。

关于Arzerra(ofatumumab):

Arzerra(ofatumumab)是一种创新的全人源化单克隆抗体,靶向B细胞表面CD20分子的一个抗原表位,该表位包含了CD20分子的胞外大环和小环结构。

Arzerra分别于2009年和2010年获FDA和EMA批准,用于对标准药物【阿仑单抗(alemtuzumab,Campath)或氟达拉滨(fludarabine)】治疗无应答的慢性淋巴细胞白血病(CLL)患者的治疗。

目前,Arzerra尚未获批用于弥漫性大B细胞淋巴瘤(DLBCL)的治疗。(生物谷Bioon.com)

英文原文:GSK and Genmab receive CHMP positive opinion for Arzerra (ofatumumab) in combination with chlorambucil or bendamustine as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL) who are not eligible for fludarabine-based therapy

Issued: Friday 23 May 2014, London UK

GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a variation to the terms of the marketing authorisation for Arzerra™ (ofatumumab) for a new indication in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.1

The CHMP recommendation of the first-line indication is based on results from two trials in patients with previously untreated CLL considered inappropriate for a fludarabine-based treatment:

Phase III OMB110911 study (COMPLEMENT 1), a randomised, open-label, parallel-arm, multicentre, pivotal Phase III study evaluating the combination of ofatumumab and chlorambucil (N=221) versus chlorambucil alone (N=226)

Phase II OMB115991, a single-arm, multicentre study that evaluated the efficacy of ofatumumab in combination with bendamustine (N= 44)

About Arzerra (ofatumumab)

Arzerra (ofatumumab) is a monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.1In the US, Arzerra® is approved (April 2014) for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.

Arzerra is also approved for first-line use in Russia.In more than 50 countries worldwide, Arzerra is indicated as monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.Arzerra is being developed under a co-development and collaboration agreement between Genmab and GSK.Arzerra is a registered trademark of the GSK group of companies.

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->