GSK单抗药Arzerra sBLA获FDA批准

关键词:单抗药,葛兰素史克,Arzerra,ofatumumab,慢性淋巴细胞白血病,CLL

2014年4月18日讯 /生物谷BIOON/ --葛兰素史克(GSK)和合作伙伴Genmab制药4月18日宣布,单抗药物Arzerra(ofatumumab,奥法木单抗)补充生物制品许可(sBLA)获FDA批准,作为一线疗法,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。

FDA批准Arzerra用于一线适应症,是基于III期COMPLEMENT1研究的数据。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。研究结果表明,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)。

此前,FDA于2013年9月授予Arzerra突破性疗法认定,并于2013年11月授予Arzerra sBLA优先审查资格。

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。

关于Arzerra(ofatumumab):

Arzerra为单抗药ofatumumab的商品名,目前正由葛兰素史克(GSK)和Genmab制药联合开发,该药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 receive FDA approval for Arzerra® (ofatumumab) as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate

GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.[1]

The FDA approval of the first-line indication is based on results from a Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.1

The results from COMPLEMENT 1, the randomised, open-label, parallel-arm, pivotal Phase III study evaluating the combination of ofatumumab and chlorambucil (N=221) versus chlorambucil alone (N=226) demonstrated statistically significant improvement in median PFS in patients randomised to ofatumumab and chlorambucil compared to patients randomised to chlorambucil alone (22.4 months versus 13.1 months, respectively) (HR=0.57 [95 per cent CI, 0.45, 0.72] p<0.001).1

The majority of adverse reactions (ARs) were Grade 2 or lower in both treatment arms. The most common (≥5 per cent in the ofatumumab plus chlorambucil arm and also ≥2 per cent more than in the chlorambucil monotherapy arm) non-infusion-related ARs (all grades) as reported by investigators within 60 days following the last treatment were neutropaenia (27 per cent ofatumumab + chlorambucil, 18 per cent chlorambucil), asthaenia (8 per cent, 5 per cent), headache (7 per cent, 3 per cent), leukopaenia (6 per cent, 2 per cent), herpes simplex (6 per cent, 4 per cent), lower respiratory tract infection (5 per cent, 3 per cent), arthralgia (5 per cent, 3 per cent), and upper abdominal pain (5 per cent, 3 per cent).1

Infusion reactions (IRs) were seen in 67 per cent of patients in the ofatumumab plus chlorambucil arm. Ten per cent of IRs were Grade 3 or greater. IRs that were Grade 3 or greater, serious or led to treatment interruption or discontinuation occurred most frequently with Cycle 1 and decreased with subsequent infusions.1

About Arzerra (ofatumumab) Arzerra (ofatumumab) is a CD20-directed monoclonal antibody indicated in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.1 Arzerra is also indicated as monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.1 Ofatumumab 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.

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