美国生物制药公司赛尔基因(Celgene)（Celgene）2月11日宣布，抗癌药Pomalyst（pomalidomide胶囊）获加拿大卫生部批准，联合地塞米松（dexamethasone），用于既往经包括来那度胺（lenalidomide）和硼替佐米（bortezomib）在内至少2种治疗方案后病情恶化的多发性骨髓瘤（multiple myeloma）的治疗。在此之前，经传统疗法治疗失败的患者，临床治疗选择十分有限。临床试验中，对来那度胺或硼替佐米治疗不再响应的多发性骨髓瘤患者群体，pomalidomide已被证明能够提高总生存率（OS），并延长无进展生存期（PFS）。
此前，加拿大卫生部已授予Pomalyst优先审查资格，该药计划于2014年3月上市。
Pomalyst的获批，是基于关键性III期MM-003研究的结果。该项研究表明，与高剂量地塞米松治疗组相比，pomalidomide+低剂量地塞米治疗组总生存期（OS）得到显著改善（12.7个月 vs 8.1个月），疾病无进展生存期（PFS）显著延长（4.0个月 vs 1.9个月，p＜0.0001）。
关于
Pomalyst（pomalidomide胶囊）由Celgene公司开发，该药是一种口服免疫调节药物，通过对耐药性骨髓瘤细胞的靶向作用，Pomalyst能够抑制细胞的生长、诱导细胞凋亡，同时增强机体自身对肿瘤的免疫反应。Pomalyst于2013年2月获FDA批准，用于其它癌症药物治疗后病情仍有进展的多发性骨髓瘤患者的治疗。
此次获批，标志着加拿大批准的第3种多发性骨髓瘤口服治疗药物。
英文原文：
2/11/2014 6:44 AM ET
Drug maker Celgene Corp. (CELG: Quote) said Tuesday that Health Canada has approved Pomalyst oral therapy (pomalidomide capsules) in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen. The company expects that Pomalyst will be commercially available in March 2014.
The company said Treatment with Pomalyst has been shown to improve rates of overall survival and extend progression-free survival in patients who no longer respond to lenalidomide or bortezomib.
Pomalyst received priority review status by Health Canada due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.
The Health Canada approval of POMALYST was based on the MM-003 pivotal study, which was published in The Lancet Oncology in October 2013. The MM-003 pivotal study demonstrated significantly improved median progression-free survival of four months (p<0.001) for patients with relapsed refractory multiple myeloma who were treated with pomalidomide plus low-dose dexamethasone, compared with 1.9 months for those treated with high-dose dexamethasone only.
Pomalyst (pomalidomide capsules) is an oral immunomodulatory drug. Through its targeted action on treatment-resistant myeloma cells, Pomalyst inhibits tumour cell growth, triggers cell death and enhances the body's own immune response to the tumour. Pomalyst was discovered and developed by Celgene, and represents the third novel oral treatment for multiple myeloma to be approved in Canada.
关键词： Celgene Pomalyst pomalidomide 多发性骨髓瘤
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