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Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO

Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO

Agios寻求FDA扩大批准Tibsovo用于IDH1-突变型胆管癌>Agio
Dow Jones Newswires ·  2021/03/01 21:59

DJ Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO

DJ Agios寻求FDA扩大批准Tibsovo用于IDH1-突变型胆管癌>Agio

By Colin Kellaher

科林·凯莱赫(Colin Kellaher)著

Agios Pharmaceuticals Inc. in Monday said it filed with the U.S. Food and Drug Administration for expanded use of Tibsovo in patients with previously treated isocitrate dehydrogenase 1, or IDH1, mutated cholangiocarcinoma.

Agios制药公司(Agios PharmPharmticals Inc.)周一表示,它向美国食品和药物管理局(U.S.Food and Drug Administration)提交了申请,要求扩大Tibsovo的使用范围,用于之前接受异柠檬酸脱氢酶1(IDH1)治疗的突变胆管癌患者。

The Cambridge, Mass., biopharmaceutical company said it also requested priority review for the application, which, if granted, could result in a six-month review process.

这家位于马萨诸塞州剑桥市的生物制药公司表示,它还要求对这项申请进行优先审查,如果获得批准,可能需要六个月的审查过程。

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease.

FDA优先审查那些有可能在治疗严重疾病方面提供重大改进的药物。

Agios said IDH1 mutations occur in roughly 13% of cases of cholangiocarcinoma, a rare and aggressive cancer of the bile ducts, adding that there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma.

Agios说,IDH1突变发生在大约13%的胆管癌病例中,胆管癌是一种罕见的侵袭性胆管癌,他补充说,目前还没有批准的系统疗法来治疗IDH1突变的胆管癌。

The FDA previously approved Tibsovo for the treatment of acute myeloid leukemia with a susceptible IDH1 mutation.

FDA此前批准Tibsovo用于治疗IDH1易感突变的急性髓系白血病。

Write to Colin Kellaher at colin.kellaher@wsj.com

写信给Colin Kellaher,电子邮件:colin.kellaher@wsj.com

(END) Dow Jones Newswires

(完)道琼通讯社

March 01, 2021 08:59 ET (13:59 GMT)

美国东部时间2021年3月1日08:59(格林尼治标准时间13:59)

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