2013年9月3日讯 --罗氏（Roche）9月2日宣布，皮下注射剂型赫赛汀（subcutaneous Herceptin，Herceptin SC）获欧盟委员会（EC）批准，用于HER2阳性乳腺癌的治疗。
目前，Herceptin通过静脉滴注（intravenous，IV）给药，全程耗时30-90分钟，皮下注射剂型Herceptin则通过皮下注射（subcutaneous，SC）给药，耗时仅为2-5分钟，创伤更小，耗时更短，为HER2阳性乳腺癌患者提供了一个重要的治疗选择。
皮下注射剂型Herceptin的获批，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相一致的疗效和安全性。
Herceptin SC是一种固定剂量（600mg/5ml）的即用型（ready-to-use）液体配方，每3周给药一次，不再需要根据患者的体重计算给药的剂量，从而简化了护理程序。
皮下注射剂型Herceptin，利用Halozyme公司新一代透明质酸酶技术开发，能够瞬时及可逆地降解皮下细胞之间的透明质酸屏障，从而使5ml体积的皮下注射剂型Herceptin在更大面积的皮下组织中迅速分散和吸收。
New formulation of Roche's Herceptin wins EU approval
Roche’s new timesaving formulation of Herceptin approved in Europe for the treatment of HER2-positive breast cancer
Subcutaneous formulation is administered in two to five minutes, rather than 30 to 90 minutes with the standard intravenous form
Herceptin is used to treat more than 80,000 patients each year in Europe
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a new injectable (subcutaneous) formulation of Herceptin (trastuzumab) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease. The approval is for both early and later stages of treatment.
“More than 90,000 women in Europe are diagnosed with HER2 positive breast cancer every year,” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased this new, formulation of Herceptin may enable patients to spend less time in the hospital and more time getting on with their lives.”
Research shows that maintaining a normal life and spending time with friends and family can improve the wellbeing of women with breast cancer1,2. The new formulation may reduce the amount of time patients spend in hospital receiving treatment with Herceptin as it can be administered at least six times faster than the standard intravenous form.
About the pivotal study
The European Commission’s approval was based on data from the HannaH study which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy (pathological complete response, pCR) to Herceptin administered intravenously in women with HER2-positive early breast cancer and resulted in non-inferior trastuzumab plasma levels. Overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting. No new safety signals were identified.
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.
Since Herceptin was first approved in 1998, this targeted medicine has been used to treat more than 1.3 million patients worldwide. 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.
The subcutaneous form of Herceptin is a ready-to-use liquid formulation that is administered as a 600 mg/5 ml fixed dose every three weeks. This simplifies healthcare procedures by removing the need for reconstitution or dose calculation according to the body weight of inpidual. A loading dose is not required when using subcutaneous administration.
The subcutaneous formulation uses technology developed by Halozyme Therapeutics, Inc. (NASDAQ: HALO) that temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the 5 ml volume of the subcutaneous formulation of Herceptin to be rapidly dispersed and absorbed over a greater area.
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