Agios submits supplemental new drug application to FDA for Tibsovo (ivosidenib) for patients with previously treated IDH1 mutant cholangiocarcinoma

Agios Pharmaceuticals

1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA for Tibsovo (ivosidenib) as a potential treatment for patients with previously treated isocitrate dehydrogenase 1 mutated cholangiocarcinoma. 

Agios has requested priority review for the application, which, if granted, could result in a six month review process.

Read Agios Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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