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FDA批准Marqibo治疗费城染色体阴性急性淋巴细胞白血病

来源:环球医学编译    时间:2012年08月10日    点击数:    5星

8月10日消息--环球医学据悉,美国食品和药物管理局于本周四表示,已批准Marqibo用于治疗一种称为费城染色体阴性急性淋巴细胞白血病的成人罕见类型白血病。

Marqib作为化疗药物长春新碱的仿制药,将成为Talon公司的第一个商业产品。

该公司主要由Warburg Pincus和 Deerfield管理,但其股票仅占非处方药股权交易的一小部分,且在下午的交易中下跌了5%。

在FDA拒绝了其他两家公司申请用于治疗复发性非霍奇金淋巴瘤的两种药物后, 2006年Talon 公司的Marqibo获得了FDA的许可。

本周四FDA批准Marqibo用于治疗至少对两种其它治疗方案无效的急性淋巴细胞白血病患者。

到目前为止,Talon的股份(在92美分的基础上下降了5%)已经翻倍。(环球医学)

 

原文

FDA approves Talon's Marqibo for rare leukemia

 

(Reuters) - The Food and Drug Administration said on Thursday it has approved Talon Therapeutics Inc's Marqibo treatment for adults with a rare form of leukemia known as Philadelphia chromosome negative acute lymphoblastic leukemia.

 

The drug, a targeted version of generic chemotherapy drug vincristine, will be the first commercial product for Talon.

 

The company is majority-owned by Warburg Pincus and Deerfield Management, but shares accounting for a minority portion of its equity trade over-the-counter and were down 5 percent in afternoon trading.

 

Talon licensed Marqibo in 2006 after the FDA turned down an application for the drug, filed by two other companies, as a treatment for relapsed non-Hodgkin's lymphoma.

 

Thursday's FDA approval is for acute lymphoblastic leukemia patients who have failed at least two other therapies.

 

Talon's shares, which were down 5 percent at 92 cents, have more than doubled so far this year.

 

相关链接:http://www.reuters.com/article/2012/08/09/us-usa-fda-leukemia-idUSBRE87812D20120809

 

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