您现在的位置:新特药 > 医药动态 > CHMP建议批准罗氏皮下注射剂型美罗华(MabThera)

CHMP建议批准罗氏皮下注射剂型美罗华(MabThera)

新药编辑:新特药 更新时间:2015-04-19

--罗氏(Roche)1月24日宣布,新剂型美罗华(MabThera/Rituxan,通用名:rituximab,利妥昔单抗)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建议欧盟委员会(EC)批准皮下注射剂型美罗华(MabThera SC,1400mg)用于非霍奇金淋巴瘤(NHL)患者的治疗。罗氏预计,EC将在未来几个月内做出最终审查决定。

目前,MabThera通过静脉滴注(intravenous,IV)给药,全程耗时2.5小时,皮下注射剂型MabThera则通过皮下注射(subcutaneous,SC)给药,耗时仅为5分钟,创伤更小,耗时更短,对患者及医护人员来说,均是一个显著改善。

CHMP的积极意见,主要基于一项2阶段、国际性III期SABRINA研究的数据,该项研究调查了MabThera SC相对于MabThera IV的药代动力学、药效和安全性,数据表明,MabThera SC具有与MabThera IV相一致的疗效和安全性,达到了非劣效性主要终点。

MabThera SC是一种固定剂量的即用型(ready-to-use)液体配方,可大大简化护理程序。

关于美罗华(MabThera/Rituxan):

美罗华(MabThera/Rituxan)是一种治疗性单克隆抗体,靶向结合正常和恶性B细胞表面的CD20抗原,随后调动人体天然防御,攻击和杀死标记的B细胞。骨髓内的干细胞(B细胞祖细胞)缺乏CD20抗原,从而使健康的B细胞能够在治疗后再生,并在几个月内恢复至正常水平。(tumor.net.cn)

英文原文:CHMP recommends EU approval of a new formulation of Roche’s MabThera for patients with non-Hodgkin lymphoma

Subcutaneous formulation to be administered under the skin over approximately five minutes compared with 2.5 hours with the current intravenous formulation

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL).

“We are excited the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time,“ said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike.”

Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources.

The CHMP opinion is based primarily on data from the phase III SABRINA study. Roche expects a final decision from the European Commission in the coming months.

About MabThera

MabThera is a therapeutic monoclonal antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera (Rituxan in the United States), discovered by Biogen Idec, first received FDA approval for the treatment of relapsed indolent NHL in 1997 and was the first targeted cancer medicine approved by the U.S. Food and Drug Administration (FDA). MabThera was approved in the EU in June 1998. For more than 15 years, the efficacy and safety of MabThera has been documented in more than 300 phase II/III clinical studies. MabThera has been approved for the treatment of several blood cancers, specifically, certain types of NHL and for chronic lymphocytic leukemia (CLL). In that time, MabThera has been used to treat more than 2.7 million people with specific blood cancers since its launch. It continues to be studied in other types of blood cancers and disease areas where CD20-positive cells are believed to play a role.

MabThera is known as Rituxan in the United States, Japan and Canada. Genentech, a member of the Roche Group, and Biogen Idec collaborate on Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

About non-Hodgkin lymphoma

There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL).

Non-Hodgkin lymphomas (NHL) are difficult-to-treat and represent approximately 84% of lymphoma diagnoses1. NHL was responsible for over 200,000 annual deaths worldwide in 20102.

Lymphomas are a cancer of the lymphatic system (composed of lymph vessels, lymph nodes and organs) which helps to keep the body fluid levels balanced and to defend the body against infectious diseases. Lymphoma develops when white blood cells (usually B-lymphocytes) in the lymph fluid become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen. Some of these cells are released into the bloodstream and spread around the body, interfering with the body’s production of healthy blood cells.

About the SABRINA study (BO22334)

SABRINA is a two-stage international phase III trial designed to investigate the pharmacokinetics, efficacy and safety of SC versus IV administration of MabThera in FL patients receiving induction and maintenance therapy. In the first stage (dose-confirmation) with pharmacokinetics (Ctrough) as primary endpoint, treatment-na?ve patients with follicular lymphoma, a common type of NHL, were randomised to receive 375 mg/m2 MabThera administered intravenously or a fixed dose of 1,400 mg of MabThera via subcutaneous delivery, both given in combination with either CHOP or CVP chemotherapy. Patients who achieved a complete or partial response after 8 treatment cycles continued MabThera maintenance therapy as per their initial randomisation with either SC or IV administration. The SABRINA study met its primary endpoint of demonstrating non-inferior MabThera serum concentration after SC injection compared with IV infusion. No new medically relevant safety signals were observed and administration related reactions were mostly of mild to moderate severity. Exploratory efficacy analysis from SABRINA was also performed to demonstrate that a switch from IV to SC administration can be achieved without compromising MabThera’s anti-lymphoma efficacy: Similar overall response rates (ORR) [84.4% IV and 90.5% SC] and complete response (CR) rates [29.7% IV and 46% SC] support the conclusion of comparable efficacy. In the second stage with efficacy as the primary endpoint, additional patients will be randomized to either SC or IV administration of M

  • 新特药:http://www.tumor.net.cn/yydt/1462.html专稿,未经书面授权请勿转载。

  • 展开