CHMP建议批准罗氏皮下注射剂型Herceptin用于HER2阳性乳腺癌

罗氏6月28日宣布，皮下注射剂型赫赛汀（Herceptin）获得了欧盟委员会（EC）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准皮下注射剂型Herceptin用于HER2阳性乳腺癌患者的治疗。

目前，Herceptin通过静脉注射给药，耗时30-90分钟。皮下注射剂型Herceptin则通过皮下注射给药，耗时仅为2-5分钟。

CHMP的积极意见是基于关键性III期HannaH研究的结果。数据表明，皮下注射剂型Herceptin具有与静脉注射剂型Herceptin相一致的安全性和疗效

英文原文：Basel, 28 June 2013 CHMP recommends EU approval of Roche's Subcutaneous Herceptin for HER2 positive breast cancer

-New injectable administration takes two to five minutes, rather than 30 to 90 minutes with the current intravenous form, potentially saving both healthcare resources and patients' time
-Herceptin® is a personalised medicine used to treat more than 80,000 HER2-positive breast cancer patients in Europe each year
Roche (SIX: RO, ROG; OTCQX: RHHBY) is pleased to announce that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has today recommended EU approval of a subcutaneous formulation of Herceptin® (trastuzumab) for the treatment of patients with HER2-positive breast cancer. Since Herceptin’s first approval in 1998 this targeted medicine has been used to treat more than 1.3 million patients worldwide.

At present, Herceptin is given to patients intravenously, which takes 30 to 90 minutes per dose. By contrast, the new subcutaneous formulation of Herceptin can be administered in two to five minutes by a simple injection under the skin.1
"Over the last 14 years, Herceptin has revolutionised the treatment of HER2-positive breast cancer. Today, more than 80,000 patients in Europe receive Herceptin each year,” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “EU approval of this subcutaneous form of Herceptin would provide a more convenient option for patients that potentially saves time and healthcare resources."

The CHMP’s positive opinion was based on data from the pivotal phase III HannaH study which showed the efficacy and safety of the subcutaneous formulation of Herceptin were comparable to treatment with Herceptin administered intravenously.1
The subcutaneous formulation of Herceptin uses technology developed by Halozyme Therapeutics, Inc. that reversibly breaks down hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the relatively large volume of the subcutaneous formulation of Herceptin to be rapidly dispersed over a greater area.

Roche is working with regulatory authorities around the world to ensure patients who are eligible for treatment with Herceptin have the option of choosing this more convenient therapy.

About Herceptin
Herceptin is a humanised monoclonal antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when it is overexpressed. The mode of action of Herceptin activates the body’s immune system and suppresses HER2 signalling to target and destroy the tumour.
Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2-positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve overall survival, response rates and disease-free survival while maintaining quality of life in women with HER2-positive breast cancer.  Eligibility for Herceptin treatment is determined by a diagnostic test, saving time from the outset by identifying those patients who would derive greater benefit from alternative treatments.
Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche.
The subcutaneous formulation of Herceptin is a ready-to-use liquid formulation that is administered as a 600 mg/5 ml fixed dose with a three weekly regimen.  This simplifies healthcare procedure, removing the need for reconstitution or dose calculation according to individual patients’ body weights. A loading dose is not required when using subcutaneous administration.