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TREAKISYM获批成为低度B细胞非霍奇金淋巴瘤和套细胞淋巴瘤抗癌剂

2017-01-19 佚名 卫材(中国)药业有限公司

®(通用名:盐酸苯达莫司汀)已在日本获得批准,作为低度B细胞非霍奇金淋巴瘤和套细胞淋巴瘤(MCL)的一线抗癌剂。 /* Style Definitions */ span.prnews_span { font-size:8pt; font-family:"Arial"; color:

上海2017年1月18日电 /美通社/ -- 卫材株式会社(总部位于日本东京,现任社长为内藤晴夫,以下简称“卫材”)今天宣布,抗癌剂TREAKISYM®(通用名:盐酸苯达莫司汀)已在日本获得批准,作为低度B细胞非霍奇金淋巴瘤和套细胞淋巴瘤(MCL)的一线抗癌剂。卫材和SymBio(总部位于东京,代表董事、总裁兼首席执行官为Fuminori Yoshida,以下简称“SymBio”)就TREAKISYM 签署授权协议。通过批准,TREAKISYM现在可以辅助利妥昔单抗治疗未经治疗的低度B细胞非霍奇金淋巴瘤和MCL。

TREAKISYM最初于2010年10月在日本获批作为复发性或难治性低度B细胞非霍奇金淋巴瘤和MCL的单一疗法。根据两家公司签订的许可协议,卫材自2010年12月开始销售该产品。2016年8月,TREAKISYM在日本获批治疗另外一种适应证—慢性淋巴细胞白血病。对于一线低度B细胞非霍奇金淋巴瘤和MCL适应证的批准,该适应证符合日本厚生劳动省福利委员会关于未经批准的药物/标签外用药的开发要求,SymBio于2015年12月提交了补充新药申请。

非霍奇金淋巴瘤是指除霍奇金淋巴瘤外,在白细胞内变异到淋巴瘤的淋巴细胞的总称,代表了日本确诊的大多数淋巴瘤。可按进展速度对非霍奇金淋巴瘤进行分类,即每年进展为低度,每月进展为中度,每周进展为高度。此外,非霍奇金淋巴瘤可进一步按癌变细胞类型(如B细胞)和细胞成熟度进行分类。由于低度B细胞非霍奇金淋巴瘤和MCL难以完全治愈,是亟需新的治疗选择的疾病。

卫材将肿瘤视为一个重点治疗领域,旨在开发具有治疗癌症潜力的革命性新药。卫材仍将致力于最大化TREAKISYM及其内部开发的抗癌剂包括Halaven®和Lenvima®的价值,从而进一步满足不同需求,为癌症患者、患者家庭及医疗从业者提供更大福祉。

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