Celgene骨髓瘤药物pomalidomide获欧盟委员会批准

2013-08-12 tomato 生物谷

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

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。

原文下载:

Oral anti-cancer therapy pomalidomide approved by EC

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    2014-03-08 cy0324
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    2013-10-24 tongyongming
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    2013-10-31 维他命
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    2013-08-14 HNYYM
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