Ivosidenib, sold under the brand name Tibsovo, is an anti-cancer medication for the treatment of acute myeloid leukemia (AML) and cholangiocarcinoma.[4] It is a small molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), which is mutated in several forms of cancer. Ivosidenib is an isocitrate dehydrogenase-1 inhibitor that works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells.[8]
Ivosidenib was approved for medical use in the United States in July 2018,[8][9][10][11] and in the European Union in May 2023.[6][12] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13]
^ ab"Tibsovo". Therapeutic Goods Administration (TGA). 19 April 2023. Archived from the original on 19 April 2023. Retrieved 29 April 2023.
^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
^"Tibsovo (Servier Laboratories (Aust) Pty Ltd)". Therapeutic Goods Administration (TGA). 26 April 2023. Retrieved 28 April 2023.
^ ab"Tibsovo- ivosidenib tablet, film coated". DailyMed. 24 April 2019. Archived from the original on 2 July 2019. Retrieved 18 December 2019.
^"Tibsovo- ivosidenib tablet, film coated". DailyMed. 9 June 2022. Archived from the original on 3 December 2022. Retrieved 3 December 2022.
^ ab"Tibsovo EPAR". European Medicines Agency (EMA). 12 May 2023. Archived from the original on 10 March 2024. Retrieved 12 May 2023.
^"Tibsovo". Union Register of medicinal products. 8 May 2023. Archived from the original on 11 May 2023. Retrieved 6 June 2023.
^ ab"FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation". U.S. Food and Drug Administration (FDA) (Press release). 20 July 2018. Archived from the original on 11 December 2019. Retrieved 18 December 2019. This article incorporates text from this source, which is in the public domain.
^"Drug Trials Snapshots: Tibsovo". U.S. Food and Drug Administration (FDA). 2 August 2018. Archived from the original on 19 December 2019. Retrieved 18 December 2019. This article incorporates text from this source, which is in the public domain.
^"FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia". U.S. Food and Drug Administration (FDA). 23 January 2019. Archived from the original on 19 December 2019. Retrieved 18 December 2019. This article incorporates text from this source, which is in the public domain.
^"Drug Approval Package: Tibsovo (ivosidenib)". U.S. Food and Drug Administration (FDA). Archived from the original on 25 June 2021. Retrieved 19 December 2019.
^"Tibsovo". Union Register of medicinal products. 8 May 2023. Archived from the original on 11 May 2023. Retrieved 12 May 2023.
^New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Archived from the original on 17 September 2020. Retrieved 16 September 2020.
Ivosidenib, sold under the brand name Tibsovo, is an anti-cancer medication for the treatment of acute myeloid leukemia (AML) and cholangiocarcinoma. It...
they are essential for the survival and proliferation of cancer cells. Ivosidenib and Enasidenib, two FDA-approved cancer treatments, can arrest the TCA...
small molecule inhibitor of isocitrate dehydrogenase 1. The FDA approved ivosidenib in August 2021 for adults with previously treated, locally advanced or...
for AML. The FDA has approved certain epigenetic modifying drugs like ivosidenib and enasidenib, which are used in patients that can no longer receive...
and in vitro, and some drugs are being developed (e.g. Ivosidenib and Vorasidenib). Ivosidenib was approved by the FDA in July 2018 for relapsed or refractory...
December 2017, the company filed a New Drug Application with the US FDA for ivosidenib for the treatment of adult patients with relapsed or refractory acute...
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This article incorporates text from this source, which is in the public domain.
