曲妥珠单抗+透明质酸
商品名：赫赛汀SC
条目类型：新剂型

英国：批准（许可）
欧盟：批准（许可）
美国：第三期临床试验
英国推出计划：仅注册用户
英国实际推出日期：
评论
9月13日：欧盟批准的[14]。
04/09/2013 10:12:23
7月13：推荐批准在欧盟对患者的治疗HER - 2阳性乳腺癌[11]
--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。

Information
Generic Name: trastuzumab + hyaluronidase
Trade Name: Herceptin SC
Entry Type: New formulation
 
Developmental Status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Sep 13: Approved in the EU [14].
04/09/2013 10:12:23
Jul 13: Recommended approval in the EU for the treatment of patients with HER2-positive breast cancer [11].
01/07/2013 09:10:22
Mar 12: Filed in EU [5].
09/03/2012 22:00:54
EU filing planned 2012 [2].
07/09/2011 17:04:03
 
Trial or other data
Aug 13: NCT01926886 is a single arm multi-centre PIII study investigating the at home administration, by a health care professional, of s.c. trastuzumab for the treatment of 100 patientswith HER2-positive early breast cancer. The primary outcome is safety. The study starts Sep 13 and is due to complete May 17 [13].
22/08/2013 11:51:28
Aug 13: Randomised PrefHer study (NCT01401166) assessing patient preference for either SC or IV trastuzumab published in Lancet Oncology. 236 women aged 18 years or older with HER2-positive, histologically confirmed primary invasive breast adenocarcinoma, no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant), an ECOG performance status of 0 or 1, and a baseline left-ventricular ejection fraction of 55% or more before the first dose of trastuzumab received four cycles of 600 mg fixed-dose SC adjuvant trastuzumab via a single-use injection device or hand-held syringe followed by four cycles of standard IV trastuzumab, or the reverse sequence. SC trastuzumab via the single-use injection device was preferred by 216 patients (91·5% [95% CI 87·2—94·7]; p<0·0001). Only 16 patients preferred IV trastuzumab (6·8% [3·9—10·8]), & four had no preference (1·7% [0·5—4·3]). Clinician-reported adverse events occurred in 141 of 242 (58%) pts during the pooled SC periods & 105 of 241 (44%) pts during the pooled IV periods; seven (3%) & five (2%) were grade 3, no pts had a grade 4 or 5 event. The most common grade 3 adverse event was influenza (0·8%) [12].
22/08/2013 10:30:03
Aug 12: HannaH published early online in Lancet Oncology [10].
10/08/2012 10:07:07
Hyaluronidase facilitates penetration & dispersion of trastuzumab by temporarily digesting hyaluronan, a major component of extracellular matrix in tissues