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Tibsovo Approval History

FDA Approved: Yes (First approved July 20, 2018)
Brand name: Tibsovo
Generic name: ivosidenib
Dosage form: Tablets
Company: Agios Pharmaceuticals, Inc.
Treatment for: Acute Myeloid Leukemia

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with acute myeloid leukemia who have an IDH1 mutation.

Development History and FDA Approval Process for Tibsovo

DateArticle
May  2, 2019Approval Agios Announces FDA Approval of Tibsovo as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy
Jul 20, 2018Approval FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
Feb 15, 2018FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation
Dec 26, 2017Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation

Further information

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