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首页 » 抗肿瘤药物市场 » 雷利度胺(Revlimid)联合地塞米松显著改善骨髓瘤患者生存

雷利度胺(Revlimid)联合地塞米松显著改善骨髓瘤患者生存

来源:生物谷 2013-08-04 17:47

2013年8月3日讯 /生物谷BIOON/ --赛尔基因(Celgene)8月2日公布了有关评价雷利米得(Revlimid,通用名:lenalidomide)联合地塞米松(dexamethasone)诱导疗法及雷利米得维持疗法用于高风险无症状性隐袭性多发性骨髓瘤(SMM)患者治疗的积极数据。

该项随机、多中心、开发标签III期研究数据显示,平均随访40个月后,与观察组相比,治疗组发展为有症状疾病的平均时间显着延长,3年总生存率也高于观察组,诱导期和维持期分别有79%和90%的患者产生部分反应,达到了研究的主要终点。该项研究已发表于8月1日版的《新英格兰医学杂志》(The New England Journal of Medicine)。(生物谷Bioon.com)

英文原文:Three-year survival improves in SMM patients treated with Revlimid, study shows

Article | 02 August 2013 US biotech firm Celgene (Nasdaq: CELG) has released positive new data evaluating treatment with Revlimid (lenalidomide) in combination with dexamethasone followed by Revlimid maintenance therapy in patients with high-risk asymptomatic smoldering multiple myeloma.

The Phase III, randomized, multicenter, open-label study, evaluated whether treatment with the combination of lenalidomide and dexamethasone followed by lenalidomide maintenance in high-risk asymptomatic smoldering multiple myeloma patients prolonged time to progression to symptomatic disease. They were compared with patients who did not receive active treatment and were just observed, which is the current standard of care for smoldering multiple myeloma.

Time to progression increases

The results were published in The New England Journal of Medicine. The article detailed that after a median follow-up of 40 months, median time to progression to symptomatic disease, the primary endpoint of the study, was significantly longer in the treatment group compared with the observation group. The three-year overall survival rate from study inclusion was also higher in the treatment group compared with the observation group. A partial response was seen in 79% of the patients in the treatment group during induction, and 90% during the maintenance phase.

Smoldering multiple myeloma is an early, asymptomatic form of the disease characterized by a 10% per year risk of progression to symptomatic disease over the first five years.

Revlimid is not approved as a treatment for smoldering multiple myeloma. It is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries. It is also approved in the USA, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due and in Europe for the treatment of patients with transfusion-dependent anemia.

Sales of Revlimid in its currently approved indications are expected to top $4.30 billion this year and were up 13% in the second quarter to $1.05 billion (The Pharma Letter July 25).

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