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Herceptin SC(曲妥珠单抗+透明质酸,赫赛汀皮下缓释注射剂)(二)
2013-09-23 17:28:20 来源: 作者: 【 】 浏览:2510次 评论:0
e eBC reported. The co-primary endpoints of pharmacokinetics and efficacy met their pre-specified criteria. Plasma concentration measured just before surgery was at least as high for the SC as for the IV formulation (69.0 and 51.8 µg/mL, respectively). In addition, efficacy as determined by pathological complete response (pCR; complete eradication of the tumour cells in the breast), was in the same range as in patients who received the and SC IV formulations(45.4% and 40.7%, respectively). The overall safety profile was consistent with that expected from treatment with Herceptin and standard chemotherapy in this setting. The results were presented at the 8th European Breast Cancer Conference (EBCC-8) in Vienna (Abstract # 1BA) [6].
02/04/2012 10:25:29
Q4 11: Positive top-line data from HANNAH (NCT00950300) trial, reported in Oct, has been accepted for presentation at EBCC 2012 [4].
06/03/2012 15:28:10
Oct 11: Positive results from the PIII showed SC injection of trastuzumab had comparable results to the IV infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required [3].
19/10/2011 09:35:05
NCT00950300: a PIII randomized open-label study comparing the pharmacokinetics, efficacy and safety of subcutaneous vs IV trastuzumab in 593 women with HER2-positive early breast cancer. Patients with operable or locally advanced breast cancer will receive pre-operative treatment with 8 cycles of chemotherapy (docetaxel followed by 5-FU/ epirubicin/ cyclophosphamide) concurrent with either SC or IV trastuzumab. After surgery patients will receive a further 10 cycles of trastuzumab SC or IV to complete 1 year of treatment. Patients will be followed for up to 2 years after the end of treatment. The primary outcome measures are: trastuzumab serum concentrations, throughout cycles 1 to 8; pathologic complete response after surgery between cycles 8 and 9. The study started in Sep 09 and is due to complete Jun 14 [1].
22/08/2011 09:00:12
 
Evidence Based eva luations
NICE (MPC) http://publications.nice.org.uk/esnm13-early-and-metastatic-her2-positive-breast-cancer-subcutaneous-trastuzumab-esnm13
NHSC http://www.nhsc-healthhorizons.org.uk/files/downloads/1052/1558.3c8869bc49189f6393ee111d4cd627c5.pdf
   
References  
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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:
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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Halozym

以下是“全球医药”详细资料
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