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GSK和Genmab向FDA提交单抗药Arzerra sBLA

来源:生物谷 2013-10-21 04:33

2013年10月20日讯 /生物谷BIOON/ --葛兰素史克(GSK)和Genmab制药10月18日宣布,已向FDA提交了一份补充生物制品许可申请(sBLA),寻求批准Arzerra(ofatumumab,奥法木单抗)联合苯丁酸氮芥(chlorambucil),用于既往未接受治疗且不适和氟达拉滨(fludarabine)疗法的慢性淋巴细胞白血病(CLL)患者的治疗。

该申请的提交,主要基于一项国际性、多中心、随机III期临床试验的结果。该试验在超过400例既往未经治疗的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。研究的相关数据已于今年5月公布,并已提交至今年12月举行的2013年美国血液学学会年度会议。

今年9月13日,FDA已授予Arzerra突破性疗法认定,与苯丁酸氮芥联合用于既往未接受治疗或不适于氟达拉滨疗法的慢性淋巴细胞白血病(CLL)患者的治疗。

慢性淋巴细胞白血病(CLL)是成人白血病中的最常见形式。据美国癌症协会(ACS)估计,2013年仅美国将新增15680例CLL患者。目前,该病尚无根治性化疗。

ofatumumab商品名为Arzerra,这是一种创新的全人源化单克隆抗体,靶向于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。(生物谷Bioon.com)

英文原文:GSK and Genmab announce submission to US regulatory authorities for Arzerra® (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL)

GlaxoSmithKline plc [LSE/NYSE: GSK] and Genmab A/S [OMX: GEN] announced today the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

The application is based primarily on results from an international, multi-centre, randomised Phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in more than 400 patients with previously untreated CLL. Headline results from this trial were announced in May, 2013 and the full study results are scheduled to be presented at the 2013 American Society of Hematology Annual Meeting in December.

About Chronic Lymphocytic Leukaemia

CLL is the most common form of leukaemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013.1 At present, no curative chemotherapy is available.

About Arzerra® (ofatumumab)

Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL.

Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops2. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GlaxoSmithKline.

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