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首页 » 抗肿瘤药物市场 » Celgene骨髓瘤药物pomalidomide获欧盟委员会批准

Celgene骨髓瘤药物pomalidomide获欧盟委员会批准

来源:生物谷 2013-08-10 16:05

2013年8月10日讯 /生物谷BIOON/ --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。(生物谷Bioon.com)

英文原文:Oral anti-cancer therapy pomalidomide approved by EC

BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that the European Commission (EC) has granted approval for Pomalidomide Celgene?▼(pomalidomide), in combination with dexamethasone, for the treatment of relapsed and refractory multiple myeloma (rrMM) in adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.1 Celgene intends to launch Pomalidomide Celgene in the EU under the trade name “IMNOVID?”, following submission of a regulatory notification to the European Medicines Agency (EMA) to change the trade name.

Multiple myeloma is a blood cancer where plasma cells, important components of the immune system which are responsible for making antibodies that help fight infections, replicate uncontrollably and accumulate in the bone marrow.2 Almost all patients with multiple myeloma have a risk of eventual relapse, which means their disease may progress even if they have achieved initial response to treatment.2,3

“Most patients diagnosed with multiple myeloma will relapse at some point and I have seen many patients who have become refractory to a number of treatments. The urgency now is to develop novel agents that help those patients who have tried several therapies and exhausted current standards of care” said Dr Xavier Leleu, H?pital Huriez, CHRU Lille, France. “The approval of pomalidomide, one of these novel agents, is great news and a major step forward for these patients across Europe who need a new effective treatment option to help manage their disease.”

Adds Alan Colowick, President of Celgene Europe, the Middle East and Africa (EMEA): “We are committed to developing life-changing medicines for those living with rare diseases. With today’s approval, Celgene becomes one of the few companies to deliver treatments across all stages of multiple myeloma, right from the start at diagnosis, through to the support that pomalidomide can now offer late-stage multiple myeloma patients who have exhausted other treatment options.”

The EC’s decision was based on the results from the MM-003 study, a phase III, multi-center, randomized (2:1), open-label study in 455 patients.1 The results demonstrated significantly improved median progression-free survival of 15.7 weeks (p<0.001) for patients with rrMM who were treated with pomalidomide plus low-dose dexamethasone, compared with 8.0 weeks (p<0.001) for those treated with high-dose dexamethasone only (data cutoff 07/09/12).1 Median overall survival was also significantly improved for the pomalidomide plus low-dose dexamethasone arm, compared with high-dose dexamethasone only, (median not reached vs. 34 weeks; p<0.001).1 The most commonly reported Grade 3 or 4 adverse reactions included neutropenia, thrombocytopenia and infections.1

The decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in May 2013.4

Pomalidomide will be launched in the European Union under the name “IMNOVID” according to local requirements.

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