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罗氏（Roche）今日宣布，FDA已接受实验性单抗药物GA101（obinutuzumab）的生物制品许可申请（BLA），同时根据III期CLL11临床研究最后一批数据，授予GA101用于既往未治疗的慢性淋巴细胞白血病（CLL）患者的优先审查资格。
FDA将在2013年11月20日作出审查决定。此前，FDA已授予GA101突破性疗法认定（Breakthrough Therapy Designation）。该认定旨在加快药物的开发及审批。
GA101是首个糖基化II型抗CD20单克隆抗体，由罗氏旗下全资子公司GlyArt AG利用其专有的抗体修饰技术GlycoMAb技术开发，该药与美罗华（Rituxan，通用名：rituximab，利妥昔单抗）均选择性靶向B细胞上的CD20蛋白，目前rituximab已获日本及海外推荐列入非霍奇金淋巴瘤的治疗指南。
美罗华（Rituxan）是一种嵌合鼠/人单克隆抗体，是全球第一个被批准用于临床治疗非霍奇金淋巴瘤（NHL）的单克隆抗体，该药的欧洲专利将于2013年底到期。GA101如果研发成功，将减小生物仿制药对美罗华的冲击。
GA101旨在增强抗体依赖性细胞毒性作用（Antibody-Dependent Cellular Cytotoxicity，ADCC）及直接的细胞死亡诱导作用（Direct Cell Death induction）。
今年4月，基于CLL11试验数据，罗氏已向FDA及欧洲药品管理局（EMA）提交了GA101的上市许可申请（marketing application）。（生物谷Bioon.com）
英文原文：FDA grants Roche’s obinutuzumab (GA101) Priority Review for previously untreated chronic lymphocytic leukemia (CLL)
Announcement follows FDA Breakthrough Therapy Designation for GA101 in CLL
FDA decision on the GA101 Biologics License Application (BLA) is expected by the end of 2013
Roche (SIX: RO, ROG; OTCQX: RHHBY): Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. This acceptance follows the GA101 FDA Breakthrough Therapy Designation that was received in May 2013.
“We’re excited that the FDA has granted GA101 in CLL both Breakthrough Therapy Designation and Priority Review,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame.”
The FDA is evaluating data from the pivotal Phase III CLL11 trial, which found that GA101 demonstrated a statistically significant 86 percent reduction in the risk of disease worsening or death (HR=0.14, 95 percent CI 0.09-0.21, p<0.0001) when combined with chlorambucil compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions. In CLL11, no new safety signals were detected for GA101. The most common Grade 3-4 adverse events (AEs) for GA101 were infusion-related reactions (IRRs) and low cell count of certain white blood cells (neutropenia) which did not result in an increased risk of infection. The incidence and severity of IRRs decreased after the first infusion and no Grade 3-4 IRRs have been reported beyond the first infusion.
Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Association (EMA) in April 2013.
About GA101
GA101 is an investigational medicine designed to attack cells that have a certain marker on their surface. It kills targeted cells both directly and together with the body’s immune system. GA101 is currently being investigated in a large clinical program, including multiple head-to-head Phase III studies versus rituximab in indolent non-Hodgkin’s lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).
About Chronic Lymphocytic Leukemia (CLL)
CLL is one of the most common forms of blood cancer and in 2013, it is expected that there will be nearly 5,000 deaths from CLL in the United States1
About FDA Breakthrough Therapy Designation
FDA ‘Breakthrough Therapy Designation’ is designed to expedite the development and review of medicines intended to treat serious and life-threatening diseases and to help ensure people have access to them through FDA approval with a shorter review time.