Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO
Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO
DJ Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO
By Colin Kellaher
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.
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.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease.
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.
The FDA previously approved Tibsovo for the treatment of acute myeloid leukemia with a susceptible IDH1 mutation.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 01, 2021 08:59 ET (13:59 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
DJ Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO
DJ Agios尋求FDA擴大批准Tibsovo用於IDH1-突變型膽管癌>Agio
By Colin Kellaher
科林·凱萊赫(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製藥公司(Agios PharmPharmticals Inc.)週一表示，它向美國食品和藥物管理局(U.S.Food and Drug Administration)提交了申請，要求擴大Tibsovo的使用範圍，用於之前接受異檸檬酸脱氫酶1(IDH1)治療的突變膽管癌患者。
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.
這家位於馬薩諸塞州劍橋市的生物製藥公司表示，它還要求對這項申請進行優先審查，如果獲得批准，可能需要六個月的審查過程。
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease.
FDA優先審查那些有可能在治療嚴重疾病方面提供重大改進的藥物。
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説，IDH1突變發生在大約13%的膽管癌病例中，膽管癌是一種罕見的侵襲性膽管癌，他補充説，目前還沒有批准的系統療法來治療IDH1突變的膽管癌。
The FDA previously approved Tibsovo for the treatment of acute myeloid leukemia with a susceptible IDH1 mutation.
FDA此前批准Tibsovo用於治療IDH1易感突變的急性髓系白血病。
Write to Colin Kellaher at colin.kellaher@wsj.com
寫信給Colin Kellaher，電子郵件：colin.kellaher@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
March 01, 2021 08:59 ET (13:59 GMT)
美國東部時間2021年3月1日08：59(格林尼治標準時間13：59)
Copyright (c) 2021 Dow Jones & Company, Inc.
版權所有(C)2021年道瓊斯公司
譯文內容由第三人軟體翻譯。
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