[{"@context":"http:\/\/schema.org\/","@type":"BlogPosting","@id":"https:\/\/wiki.edu.vn\/en\/wiki41\/ivosidenib-wikipedia\/#BlogPosting","mainEntityOfPage":"https:\/\/wiki.edu.vn\/en\/wiki41\/ivosidenib-wikipedia\/","headline":"Ivosidenib – Wikipedia","name":"Ivosidenib – Wikipedia","description":"before-content-x4 From Wikipedia, the free encyclopedia after-content-x4 Anti-cancer medication Ivosidenib, sold under the brand name Tibsovo, is an anti-cancer medication","datePublished":"2019-12-09","dateModified":"2019-12-09","author":{"@type":"Person","@id":"https:\/\/wiki.edu.vn\/en\/wiki41\/author\/lordneo\/#Person","name":"lordneo","url":"https:\/\/wiki.edu.vn\/en\/wiki41\/author\/lordneo\/","image":{"@type":"ImageObject","@id":"https:\/\/secure.gravatar.com\/avatar\/c9645c498c9701c88b89b8537773dd7c?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/c9645c498c9701c88b89b8537773dd7c?s=96&d=mm&r=g","height":96,"width":96}},"publisher":{"@type":"Organization","name":"Enzyklop\u00e4die","logo":{"@type":"ImageObject","@id":"https:\/\/wiki.edu.vn\/wiki4\/wp-content\/uploads\/2023\/08\/download.jpg","url":"https:\/\/wiki.edu.vn\/wiki4\/wp-content\/uploads\/2023\/08\/download.jpg","width":600,"height":60}},"image":{"@type":"ImageObject","@id":"https:\/\/upload.wikimedia.org\/wikipedia\/en\/thumb\/6\/62\/PD-icon.svg\/12px-PD-icon.svg.png","url":"https:\/\/upload.wikimedia.org\/wikipedia\/en\/thumb\/6\/62\/PD-icon.svg\/12px-PD-icon.svg.png","height":"12","width":"12"},"url":"https:\/\/wiki.edu.vn\/en\/wiki41\/ivosidenib-wikipedia\/","wordCount":5082,"articleBody":"     (adsbygoogle = window.adsbygoogle || []).push({});before-content-x4From Wikipedia, the free encyclopedia       (adsbygoogle = window.adsbygoogle || []).push({});after-content-x4Anti-cancer medicationIvosidenib, sold under the brand name Tibsovo, is an anti-cancer medication for the treatment of acute myeloid leukemia (AML) and cholangiocarcinoma.[1] 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.[3]       (adsbygoogle = window.adsbygoogle || []).push({});after-content-x4Ivosidenib was approved for medical use in the United States in July 2018.[3][4][5][6] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]Table of ContentsMedical uses[edit]Adverse effects[edit]History[edit]Society and culture[edit]Legal status[edit]Research[edit]References[edit]External links[edit]Medical uses[edit]Ivosidenib is indicated for people with acute myeloid leukemia and locally advanced or metastatic cholangiocarcinoma.[1][8][9]       (adsbygoogle = window.adsbygoogle || []).push({});after-content-x4Adverse effects[edit]In ivosidenib-treated patients, reported adverse effects have been febrile neutropenia, alanine aminotransferase increased, aspartate aminotransferase increased, colitis, hypertension, maculopapular rash. However, Ivosidenib was taken in conjunction with standard AML induction treatment, and side effects can not be directly related to the drug.[10]History[edit]The US Food and Drug Administration (FDA) awarded orphan drug designations for acute myeloid leukemia and for cholangiocarcinoma.[11][12][13][14]Society and culture[edit]Legal status[edit]On 23 February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tidhesco, intended for the treatment of adults with for newly diagnosed acute myeloid leukemia.[15] The applicant for this medicinal product is Les Laboratoires Servier.[15]On 23 February 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tibsovo, intended for the treatment of adults with newly diagnosed acute myeloid leukemia and for the treatment of adults with locally advanced or metastatic cholangiocarcinoma.[16] The applicant for this medicinal product is Les Laboratoires Servier.[16]Research[edit]In tumors from people diagnosed with glioma, acute myeloid leukemia (AML), cholangiocarcinoma, and chondrosarcoma, somatic mutations in the conserved active site of isocitrate dehydrogenase (IDH) 1 and 2 are observed. With these new mutations, these enzymes exhibit new, neomorphic behavior, which results in the reduction of \u03b1-ketoglutarate to the oncometabolite R-2-hydroxyglutarate. The new molecule competitively inhibits \u03b1-ketoglutarate\u2013dependent enzymes, ultimately leading to epigenetic alterations and impaired hematopoietic differentiation. Mutations in the IDH1 enzyme mutations occur in approximately 6 to 10% of the patients with AML, and IDH2 mutations occur in approximately 9 to 13% of those with AML, with unknown statistics on other conditions listed.[17]The drug is also believed to believed to be a slow-binding inhibitor of the IDH1-WT homodimer. Ivosidenib showed uncompetitive inhibition to the NADP cofactor, showing a hyperbolic curve for the rate constant of inhibition relative to concentration. Ivosidenib also showed no time-dependence in IC50 between 1 and 16 hours of incubation for either homodimer.[18]References[edit]^ a b c “Tibsovo- ivosidenib tablet, film coated”. DailyMed. 24 April 2019. Retrieved 18 December 2019.^ “Tibsovo- ivosidenib tablet, film coated”. DailyMed. 9 June 2022. Retrieved 3 December 2022.^ a b “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).^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.^ “FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation”. U.S. Food and Drug Administration (FDA). 3 May 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.^ “FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma”. U.S. Food and Drug Administration (FDA). 26 August 2021. Retrieved 26 August 2021.^ Stein EM, DiNardo CD, Mims AS, Savona MR, Pratz K, Stein AS,  et\u00a0al. (7 December 2017). “Ivosidenib or Enasidenib Combined with Standard Induction Chemotherapy Is Well Tolerated and Active in Patients with Newly Diagnosed AML with an IDH1 or IDH2 Mutation: Initial Results from a Phase 1 Trial”. Blood. 130 (Suppl 1): 726. doi:10.1182\/blood.V130.Suppl_1.726.726.^ “Tibsovo Orphan Drug Designation and Approval”. U.S. Food and Drug Administration (FDA). Retrieved 18 December 2019.^ “Ivosidenib Orphan Drug Designation and Approval”. U.S. Food and Drug Administration (FDA). Retrieved 18 December 2019.^ “Ivosidenib Orphan Drug Designations and Approvals”. U.S. Food and Drug Administration (FDA). Retrieved 26 August 2021.^ “Ivosidenib Orphan Drug Designations and Approvals”. U.S. Food and Drug Administration (FDA). Retrieved 26 August 2021.^ a b “Tidhesco: Pending EC decision”. European Medicines Agency. 24 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.^ a b “Tibsovo: Pending EC decision”. European Medicines Agency. 24 February 2023. Retrieved 24 February 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.^ DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS,  et\u00a0al. (June 2018). “Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML”. The New England Journal of Medicine. 378 (25): 2386\u20132398. doi:10.1056\/NEJMoa1716984. PMID\u00a029860938. S2CID\u00a0205102890.^ Popovici-Muller J, Lemieux RM, Artin E, Saunders JO, Salituro FG, Travins J,  et\u00a0al. (April 2018). “Discovery of AG-120 (Ivosidenib): A First-in-Class Mutant IDH1 Inhibitor for the Treatment of IDH1 Mutant Cancers”. ACS Medicinal Chemistry Letters. 9 (4): 300\u2013305. doi:10.1021\/acsmedchemlett.7b00421. PMC\u00a05900343. PMID\u00a029670690.External links[edit]“Ivosidenib”. Drug Information Portal. U.S. National Library of Medicine.Clinical trial number NCT02074839 for “Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation” at ClinicalTrials.govClinical trial number NCT02989857 for “Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) (ClarIDHy)” at ClinicalTrials.govCI monoclonal antibodies (“-mab”)Tyrosine kinase inhibitors (“-nib”)Receptor tyrosine kinaseRET inhibitors: Entrectinib (ALK, ROS1, NTRK), Futibatinib (FGFR2), Infigratinib, Larotrectinib (NTRK), Pemigatinib (FGFR), Pralsetinib, Selpercatinib (VEGFR, FGFR), Vandetanib (VEGFR, EGFR).Non-receptorOther     (adsbygoogle = window.adsbygoogle || []).push({});after-content-x4"},{"@context":"http:\/\/schema.org\/","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"https:\/\/wiki.edu.vn\/en\/wiki41\/#breadcrumbitem","name":"Enzyklop\u00e4die"}},{"@type":"ListItem","position":2,"item":{"@id":"https:\/\/wiki.edu.vn\/en\/wiki41\/ivosidenib-wikipedia\/#breadcrumbitem","name":"Ivosidenib – Wikipedia"}}]}]