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  药店国别: 德国药房
产地国家: 德国
所属类别: 抗癌药物->治疗骨肉瘤
处方药:处方药
包装规格: 2毫克/胶囊 21胶囊/盒
计价单位:
   
生产厂家中文参考译名:
赛尔基因
生产厂家英文名:
Celgene Gmbh
原产地英文商品名:
Imnovid 2mg 21 caps
原产地英文药品名:
Pomalidomide
中文参考商品译名:
Imnovid 2毫克/胶囊 21胶囊/盒
中文参考药品译名:
泊马度胺
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Multiple Myeloma
临床试验期:
完成
中文适应病症参考翻译1:
多发性骨髓瘤
药品信息:
赛尔基因(Celgene)8月9日宣布,口服抗癌药物pomalidomide已获欧盟委员会(EC)批准,联合地塞米松(dexamethasone)用于既往已接受过至少2次治疗[包括雷利度胺( lenalidomide)和硼替佐米(bortezomib)]、且最后一次治疗后经证实病情恶化的复发性和难治性多发性骨髓瘤(rrMM)成人患者的治疗。 在向欧洲药品管理局(EMA)提交更改商品名的通知后,Celgene拟在欧盟以品牌名IMNOVID推出该药。 多发性骨髓瘤(MM)是一种血液癌症,是由于浆细胞(plasma cells)不受控制的复制及在骨髓中的聚集所致。几乎所有的患者都有最终复发(eventual relapse)的风险,这意味着即便获得初步治疗,患者的病情仍可能恶化。 该药的获批,是基于MM-003研究的数据,这是一个多中心、随机、开发标签III期研究,涉及455例患者,该项研究达到了改善无进展生存期(PFS)的主要终点,同时也达到了改善总生存期(OS)的次要终点,PFS和OS的改善均达到了高度统计学显着意义及临床意义。 MM-003研究中,高剂量地塞米松对照组PFS为8.0周,pomalidomide+低剂量地塞米松治疗组PFS为15.7周,具有高度统计学显着差异(15.7周 vs 8.0周,p<0.001,数据截止2012年9月7日)。高剂量地塞米松对照组OS为34周,pomalidomide+低剂量地塞米松治疗组OS数据尚未得出,同样具有高度统计学显着差异(未得出 vs 34周,p<0.001)。 今年5月,pomalidomide也获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)建议批准的积极意见 Celgene announced on August 9 , oral anti-cancer drug pomalidomide has been the European Commission (EC) approved in combination with dexamethasone (dexamethasone) to have received at least two previous treatments [ including lenalidomide ( lenalidomide) and bortezomib (bortezomib)], and the last confirmed recurrent disease progression and refractory multiple myeloma (rrMM) adult patients after treatment . After submitting the trade name change notification to the European Medicines Agency (EMA), Celgene intends to launch EU IMNOVID brand name drug . Multiple myeloma (MM) is a cancer of the blood , is due to plasma cells (plasma cells) uncontrolled replication and gathered in the bone marrow due. Almost all patients have the risk of eventually relapse (eventual relapse) , which means that even access to initial treatment , the patient 's condition could still worsen . The drug 's approval was based on data MM-003 study, which is a multi- center, randomized, Phase III development label study involving 455 cases of patients , the study reached the improving progression-free survival (PFS) in the primary endpoint , but also to improve overall survival reached (OS), a secondary endpoint , PFS , and OS improvements have reached the height of a significant statistical and clinical significance. MM-003 studies, high doses of dexamethasone in the control group PFS was 8.0 weeks , pomalidomide + low- dose dexamethasone treatment group PFS was 15.7 weeks , with a highly statistically significant difference ( 15.7 weeks vs 8.0周, p <0.001, data As of September 7, 2012 ) . High -dose dexamethasone group OS was 34 weeks , pomalidomide + low- dose dexamethasone treatment group OS data has not yet come , also has a highly statistically significant difference (not drawn vs 34周, p <0.001). In May this year , pomalidomide also won the European Medicines Agency (EMA) recommended the approval of man Committee for Medicinal Products (CHMP) positive opinion
更新日期: 2014-04-28
附件:
20146318510714.pdf    

 
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