Vorasidenib: Difference between revisions
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{{Short description|Anti-cancer medication}} |
{{Short description|Anti-cancer medication}} |
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{{Use American English|date=August 2024}} |
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{{Use dmy dates|date=May 2024}} |
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{{Infobox drug |
{{Infobox drug |
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| image = Vorasidenib v2.svg |
| image = Vorasidenib v2.svg |
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<!-- Clinical data --> |
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| pronounce = |
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| tradename = |
| tradename = Voranigo |
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| Drugs.com = |
| Drugs.com = {{drugs.com|parent|Voranigo}} |
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| MedlinePlus = |
| MedlinePlus = |
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| DailyMedID = Vorasidenib |
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| pregnancy_AU = D |
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| routes_of_administration = [[By mouth]] |
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| ATC_prefix = None <!-- Scheduled to be L01XM04 in 2025 --> |
| ATC_prefix = None <!-- Scheduled to be L01XM04 in 2025 --> |
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<!-- Legal status --> |
<!-- Legal status --> |
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| legal_AU = S4 |
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| legal_AU_comment = <ref name="Voranigo APMDS">{{cite web | title=Voranigo (vorasidenib) | website=Therapeutic Goods Administration (TGA) | date=26 September 2024 | url=https://www.tga.gov.au/resources/auspmd/voranigo-vorasidenib | access-date=12 October 2024}}</ref> |
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| legal_CA = Rx-only |
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| legal_CA_comment = <ref>{{cite web | title=Notice: Multiple additions to the Prescription Drug List (PDL) [2024-10-18] | website=[[Health Canada]] | date=18 October 2024 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2024-10-18.html | access-date=25 October 2024}}</ref> |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> |
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| legal_US = |
| legal_US = Rx-only |
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| legal_US_comment = <ref name="Voranigo FDA label">{{cite web | title=Voranigo- vorasidenib citrate tablet, film coated | website=DailyMed | date=9 August 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=31405fee-55b7-4857-987e-2724ee76be84 | access-date=15 August 2024}}</ref> |
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| PubChem = 117817422 |
| PubChem = 117817422 |
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| IUPHAR_ligand = 10663 |
| IUPHAR_ligand = 10663 |
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| DrugBank = DB17097 |
| DrugBank = DB17097 |
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| ChemSpiderID = 64835242 |
| ChemSpiderID = 64835242 |
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| UNII = 789Q85GA8P |
| UNII = 789Q85GA8P |
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| KEGG = |
| KEGG = D11834 |
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| ChEMBL = 4279047 |
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'''Vorasidenib''', sold under the brand name '''Voranigo''', is an [[anti-cancer medication]] used for the treatment of certain forms of [[glioma]].<ref name="Voranigo FDA label" /><ref name="FDA 20240806" /> Vorasidenib is a dual mutant [[IDH1|isocitrate dehydrogenase 1]] and [[IDH2|isocitrate dehydrogenase 2]] (mIDH1/2) inhibitor.<ref name="Voranigo FDA label" /><ref name="FDA 20240806" /> |
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'''Vorasidenib''' is an experimental [[anti-cancer medication]] for the treatment of low-grade [[glioma]]. It is a [[targeted therapy|small molecule inhibitor]] of [[IDH1|isocitrate dehydrogenase-1]] (IDH1) and [[IDH2|isocitrate dehydrogenase-2]] (IDH2), which are mutated in several forms of [[cancer]].<ref name="Vorasidenib">{{cite web | title=Vorasidenib compound summary | website=pubchem | date=2 September 2023 | url=https://pubchem.ncbi.nlm.nih.gov/compound/Vorasidenib | access-date=6 September 2023}}</ref> In a phase-III-trial, it was shown to prolong progression-free survival in patients with IDH1- or IDH2-mutant low-grade glioma.<ref name = "Mellinghoff23">{{citation|first=Ingo K.|last=Mellinghoff|display-authors=et al.|date=2023-08-17|doi=10.1056/NEJMoa2304194|issue=7|pages=389–601|periodical=New England Journal of Medicine|pmc=5900343|pmid=29670690|title=Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma|volume=389}}<!-- auto-translated by Module:CS1 translator --></ref> |
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The most common adverse reactions include [[fatigue]], [[headache]], [[Immunosuppression|increased risk of COVID-19 infection]], [[musculoskeletal pain]], [[diarrhea]], [[nausea]], and [[seizure]]s.<ref name="FDA 20240806" /> |
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Vorasidenib was approved for medical use in the United States in August 2024.<ref name="FDA 20240806">{{cite web | title=FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation | website=U.S. [[Food and Drug Administration]] (FDA) | date=6 August 2024 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation | access-date=7 August 2024 | archive-date=7 August 2024 | archive-url=https://web.archive.org/web/20240807035511/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation | url-status=live }} {{PD-notice}}</ref><ref>{{cite press release | title=Servier's Voranigo (vorasidenib) Tablets Receives FDA Approval as First Targeted Therapy for Grade 2 IDH-mutant Glioma | publisher=Servier Pharmaceuticals | via=PR Newswire | date=6 August 2024 | url=https://www.prnewswire.com/news-releases/serviers-voranigo-vorasidenib-tablets-receives-fda-approval-as-first-targeted-therapy-for-grade-2-idh-mutant-glioma-302215991.html | access-date=7 August 2024 | archive-date=7 August 2024 | archive-url=https://web.archive.org/web/20240807072643/https://www.prnewswire.com/news-releases/serviers-voranigo-vorasidenib-tablets-receives-fda-approval-as-first-targeted-therapy-for-grade-2-idh-mutant-glioma-302215991.html | url-status=live }}</ref> It is the first approval by the US [[Food and Drug Administration]] (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation.<ref name="FDA 20240806" /> |
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== Medical uses == |
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Vorasidenib is [[indicated]] for the treatment of people aged twelve years of age and older with grade 2 [[astrocytoma]] or [[oligodendroglioma]] with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation, following [[surgery]] including [[biopsy]], sub-total resection, or gross total resection.<ref name="FDA 20240806" /> |
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== Side effects == |
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The most common adverse reactions include fatigue, headache, [[Immunosuppression|increased risk of COVID-19 infection]], musculoskeletal pain, diarrhea, nausea, and seizures.<ref name="FDA 20240806" /> The most common grade 3 or 4 laboratory abnormalities include increased alanine aminotransferase, increased aspartate aminotransferase, GGT increased, and decreased neutrophils.<ref name="FDA 20240806" /> |
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== Pharmacology == |
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[[Agios Pharmaceuticals]] previously developed the mIDH1 inhibitor [[ivosidenib]]<ref>{{cite journal | vauthors = Popovici-Muller J, Lemieux RM, Artin E, Saunders JO, Salituro FG, Travins J, Cianchetta G, Cai Z, Zhou D, Cui D, Chen P, Straley K, Tobin E, Wang F, David MD, Penard-Lacronique V, Quivoron C, Saada V, de Botton S, Gross S, Dang L, Yang H, Utley L, Chen Y, Kim H, Jin S, Gu Z, Yao G, Luo Z, Lv X, Fang C, Yan L, Olaharski A, Silverman L, Biller S, Su SM, Yen K | title = Discovery of AG-120 (Ivosidenib): A First-in-Class Mutant IDH1 Inhibitor for the Treatment of IDH1 Mutant Cancers | journal = ACS Medicinal Chemistry Letters | volume = 9 | issue = 4 | pages = 300–305 | date = April 2018 | pmid = 29670690 | pmc = 5900343 | doi = 10.1021/acsmedchemlett.7b00421 }}</ref> and mIDH2 inhibitor [[enasidenib]]<ref>{{Cite journal | vauthors = Shih AH, Shank KR, Meydan C, Intlekofer AM, Ward P, Thompson CB, Melnick AM, Travins J, Straley K, Gliser C, Yen K |date=2014-12-06 |title=AG-221, a Small Molecule Mutant IDH2 Inhibitor, Remodels the Epigenetic State of IDH2-Mutant Cells and Induces Alterations in Self-Renewal/Differentiation in IDH2-Mutant AML Model in Vivo |url=https://ashpublications.org/blood/article/124/21/437/91960/AG221-a-Small-Molecule-Mutant-IDH2-Inhibitor |journal=Blood |language=en |volume=124 |issue=21 |pages=437 |doi=10.1182/blood.V124.21.437.437 |issn=0006-4971}}</ref><ref>{{cite journal | vauthors = Yen K, Travins J, Wang F, David MD, Artin E, Straley K, Padyana A, Gross S, DeLaBarre B, Tobin E, Chen Y, Nagaraja R, Choe S, Jin L, Konteatis Z, Cianchetta G, Saunders JO, Salituro FG, Quivoron C, Opolon P, Bawa O, Saada V, Paci A, Broutin S, Bernard OA, de Botton S, Marteyn BS, Pilichowska M, Xu Y, Fang C, Jiang F, Wei W, Jin S, Silverman L, Liu W, Yang H, Dang L, Dorsch M, Penard-Lacronique V, Biller SA, Su SM | title = AG-221, a First-in-Class Therapy Targeting Acute Myeloid Leukemia Harboring Oncogenic <i>IDH2</i> Mutations | journal = Cancer Discovery | volume = 7 | issue = 5 | pages = 478–493 | date = May 2017 | pmid = 28193778 | doi = 10.1158/2159-8290.CD-16-1034 }}</ref> for treatment of [[Acute myeloid leukemia|acute myeloid leukemia (AML)]] with susceptible IDH1 or IDH2 mutations, respectively. However, ivosidenib and enasidenib have low brain exposure, precluding their use in gliomas.<ref name=":0">{{cite journal | vauthors = Konteatis Z, Artin E, Nicolay B, Straley K, Padyana AK, Jin L, Chen Y, Narayaraswamy R, Tong S, Wang F, Zhou D, Cui D, Cai Z, Luo Z, Fang C, Tang H, Lv X, Nagaraja R, Yang H, Su SM, Sui Z, Dang L, Yen K, Popovici-Muller J, Codega P, Campos C, Mellinghoff IK, Biller SA | title = Vorasidenib (AG-881): A First-in-Class, Brain-Penetrant Dual Inhibitor of Mutant IDH1 and 2 for Treatment of Glioma | journal = ACS Medicinal Chemistry Letters | volume = 11 | issue = 2 | pages = 101–107 | date = February 2020 | pmid = 32071674 | pmc = 7025383 | doi = 10.1021/acsmedchemlett.9b00509 }}</ref> Moreover, isoform switching between IDH1 and IDH2 has been observed as a mechanism of resistance to mIDH inhibitor therapy.<ref>{{cite journal | vauthors = Harding JJ, Lowery MA, Shih AH, Schvartzman JM, Hou S, Famulare C, Patel M, Roshal M, Do RK, Zehir A, You D, Selcuklu SD, Viale A, Tallman MS, Hyman DM, Reznik E, Finley LW, Papaemmanuil E, Tosolini A, Frattini MG, MacBeth KJ, Liu G, Fan B, Choe S, Wu B, Janjigian YY, Mellinghoff IK, Diaz LA, Levine RL, Abou-Alfa GK, Stein EM, Intlekofer AM | title = Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition | journal = Cancer Discovery | volume = 8 | issue = 12 | pages = 1540–1547 | date = December 2018 | pmid = 30355724 | pmc = 6699636 | doi = 10.1158/2159-8290.CD-18-0877 }}</ref> Vorasidenib was thus developed to improve [[Blood–brain barrier|blood-brain barrier]] penetration and inhibit both mIDH1/2.<ref name=":0" /> |
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== History == |
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Efficacy was evaluated in 331 participants with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation following surgery enrolled in INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial.<ref name="FDA 20240806" /> Participants were randomized 1:1 to receive vorasidenib 40 mg orally once daily or placebo orally once daily until disease progression or unacceptable toxicity.<ref name="FDA 20240806" /> Isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation status was prospectively determined by the Life Technologies Corporation Oncomine Dx Target Test.<ref name="FDA 20240806" /> Participants randomized to placebo were allowed to cross over to vorasidenib after documented radiographic disease progression.<ref name="FDA 20240806" /> Participants who received prior anti-cancer treatment, including chemotherapy or radiation therapy, were excluded.<ref name="FDA 20240806" /> |
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== Society and culture == |
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=== Legal status === |
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Vorasidenib was approved for medical use in the United States in August 2024.<ref name="FDA 20240806" /> |
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The FDA granted the application for vorasidenib [[priority review]], [[Fast track (FDA)|fast track]], [[breakthrough therapy]], and [[orphan drug]] designations.<ref name="FDA 20240806" /> |
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== References == |
== References == |
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{{reflist}} |
{{reflist}} |
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== Further reading == |
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{{refbegin}} |
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* {{cite journal | vauthors = Mellinghoff IK, Lu M, Wen PY, Taylor JW, Maher EA, Arrillaga-Romany I, Peters KB, Ellingson BM, Rosenblum MK, Chun S, Le K, Tassinari A, Choe S, Toubouti Y, Schoenfeld S, Pandya SS, Hassan I, Steelman L, Clarke JL, Cloughesy TF | title = Vorasidenib and ivosidenib in IDH1-mutant low-grade glioma: a randomized, perioperative phase 1 trial | journal = Nature Medicine | volume = 29 | issue = 3 | pages = 615–622 | date = March 2023 | pmid = 36823302 | pmc = 10313524 | doi = 10.1038/s41591-022-02141-2 }} |
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* {{cite journal | vauthors = Mellinghoff IK, Penas-Prado M, Peters KB, Burris HA, Maher EA, Janku F, Cote GM, de la Fuente MI, Clarke JL, Ellingson BM, Chun S, Young RJ, Liu H, Choe S, Lu M, Le K, Hassan I, Steelman L, Pandya SS, Cloughesy TF, Wen PY | title = Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial | journal = Clinical Cancer Research | volume = 27 | issue = 16 | pages = 4491–4499 | date = August 2021 | pmid = 34078652 | pmc = 8364866 | doi = 10.1158/1078-0432.CCR-21-0611 }} |
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* {{cite journal | vauthors = Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF | title = Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma | journal = The New England Journal of Medicine | volume = 389 | issue = 7 | pages = 589–601 | date = August 2023 | pmid = 37272516 | pmc = 11445763 | doi = 10.1056/NEJMoa2304194 }} |
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* {{cite journal | vauthors = Popovici-Muller J, Lemieux RM, Artin E, Saunders JO, Salituro FG, Travins J, Cianchetta G, Cai Z, Zhou D, Cui D, Chen P, Straley K, Tobin E, Wang F, David MD, Penard-Lacronique V, Quivoron C, Saada V, de Botton S, Gross S, Dang L, Yang H, Utley L, Chen Y, Kim H, Jin S, Gu Z, Yao G, Luo Z, Lv X, Fang C, Yan L, Olaharski A, Silverman L, Biller S, Su SM, Yen K | title = Discovery of AG-120 (Ivosidenib): A First-in-Class Mutant IDH1 Inhibitor for the Treatment of IDH1 Mutant Cancers | journal = ACS Medicinal Chemistry Letters | volume = 9 | issue = 4 | pages = 300–305 | date = April 2018 | pmid = 29670690 | pmc = 5900343 | doi = 10.1021/acsmedchemlett.7b00421 }} |
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{{refend}} |
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== External links == |
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* {{ClinicalTrialsGov|NCT04164901|Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)}} |
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* {{ClinicalTrialsGov|NCT02481154|Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation}} |
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* {{ClinicalTrialsGov|NCT03343197|Study of AG-120 and AG-881 in Subjects With Low Grade Glioma}} |
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Latest revision as of 15:26, 1 November 2024
Clinical data | |
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Trade names | Voranigo |
AHFS/Drugs.com | Voranigo |
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Routes of administration | By mouth |
ATC code |
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PubChem CID | |
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Chemical and physical data | |
Formula | C14H13ClF6N6 |
Molar mass | 414.74 g·mol−1 |
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Vorasidenib, sold under the brand name Voranigo, is an anti-cancer medication used for the treatment of certain forms of glioma.[3][4] Vorasidenib is a dual mutant isocitrate dehydrogenase 1 and isocitrate dehydrogenase 2 (mIDH1/2) inhibitor.[3][4]
The most common adverse reactions include fatigue, headache, increased risk of COVID-19 infection, musculoskeletal pain, diarrhea, nausea, and seizures.[4]
Vorasidenib was approved for medical use in the United States in August 2024.[4][5] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation.[4]
Medical uses
[edit]Vorasidenib is indicated for the treatment of people aged twelve years of age and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.[4]
Side effects
[edit]The most common adverse reactions include fatigue, headache, increased risk of COVID-19 infection, musculoskeletal pain, diarrhea, nausea, and seizures.[4] The most common grade 3 or 4 laboratory abnormalities include increased alanine aminotransferase, increased aspartate aminotransferase, GGT increased, and decreased neutrophils.[4]
Pharmacology
[edit]Agios Pharmaceuticals previously developed the mIDH1 inhibitor ivosidenib[6] and mIDH2 inhibitor enasidenib[7][8] for treatment of acute myeloid leukemia (AML) with susceptible IDH1 or IDH2 mutations, respectively. However, ivosidenib and enasidenib have low brain exposure, precluding their use in gliomas.[9] Moreover, isoform switching between IDH1 and IDH2 has been observed as a mechanism of resistance to mIDH inhibitor therapy.[10] Vorasidenib was thus developed to improve blood-brain barrier penetration and inhibit both mIDH1/2.[9]
History
[edit]Efficacy was evaluated in 331 participants with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation following surgery enrolled in INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial.[4] Participants were randomized 1:1 to receive vorasidenib 40 mg orally once daily or placebo orally once daily until disease progression or unacceptable toxicity.[4] Isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation status was prospectively determined by the Life Technologies Corporation Oncomine Dx Target Test.[4] Participants randomized to placebo were allowed to cross over to vorasidenib after documented radiographic disease progression.[4] Participants who received prior anti-cancer treatment, including chemotherapy or radiation therapy, were excluded.[4]
Society and culture
[edit]Legal status
[edit]Vorasidenib was approved for medical use in the United States in August 2024.[4]
The FDA granted the application for vorasidenib priority review, fast track, breakthrough therapy, and orphan drug designations.[4]
References
[edit]- ^ a b "Voranigo (vorasidenib)". Therapeutic Goods Administration (TGA). 26 September 2024. Retrieved 12 October 2024.
- ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-10-18]". Health Canada. 18 October 2024. Retrieved 25 October 2024.
- ^ a b c "Voranigo- vorasidenib citrate tablet, film coated". DailyMed. 9 August 2024. Retrieved 15 August 2024.
- ^ a b c d e f g h i j k l m n o "FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation". U.S. Food and Drug Administration (FDA). 6 August 2024. Archived from the original on 7 August 2024. Retrieved 7 August 2024. This article incorporates text from this source, which is in the public domain.
- ^ "Servier's Voranigo (vorasidenib) Tablets Receives FDA Approval as First Targeted Therapy for Grade 2 IDH-mutant Glioma" (Press release). Servier Pharmaceuticals. 6 August 2024. Archived from the original on 7 August 2024. Retrieved 7 August 2024 – via PR Newswire.
- ^ Popovici-Muller J, Lemieux RM, Artin E, Saunders JO, Salituro FG, Travins J, et al. (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): 300–305. doi:10.1021/acsmedchemlett.7b00421. PMC 5900343. PMID 29670690.
- ^ Shih AH, Shank KR, Meydan C, Intlekofer AM, Ward P, Thompson CB, et al. (6 December 2014). "AG-221, a Small Molecule Mutant IDH2 Inhibitor, Remodels the Epigenetic State of IDH2-Mutant Cells and Induces Alterations in Self-Renewal/Differentiation in IDH2-Mutant AML Model in Vivo". Blood. 124 (21): 437. doi:10.1182/blood.V124.21.437.437. ISSN 0006-4971.
- ^ Yen K, Travins J, Wang F, David MD, Artin E, Straley K, et al. (May 2017). "AG-221, a First-in-Class Therapy Targeting Acute Myeloid Leukemia Harboring Oncogenic IDH2 Mutations". Cancer Discovery. 7 (5): 478–493. doi:10.1158/2159-8290.CD-16-1034. PMID 28193778.
- ^ a b Konteatis Z, Artin E, Nicolay B, Straley K, Padyana AK, Jin L, et al. (February 2020). "Vorasidenib (AG-881): A First-in-Class, Brain-Penetrant Dual Inhibitor of Mutant IDH1 and 2 for Treatment of Glioma". ACS Medicinal Chemistry Letters. 11 (2): 101–107. doi:10.1021/acsmedchemlett.9b00509. PMC 7025383. PMID 32071674.
- ^ Harding JJ, Lowery MA, Shih AH, Schvartzman JM, Hou S, Famulare C, et al. (December 2018). "Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition". Cancer Discovery. 8 (12): 1540–1547. doi:10.1158/2159-8290.CD-18-0877. PMC 6699636. PMID 30355724.
Further reading
[edit]- Mellinghoff IK, Lu M, Wen PY, Taylor JW, Maher EA, Arrillaga-Romany I, et al. (March 2023). "Vorasidenib and ivosidenib in IDH1-mutant low-grade glioma: a randomized, perioperative phase 1 trial". Nature Medicine. 29 (3): 615–622. doi:10.1038/s41591-022-02141-2. PMC 10313524. PMID 36823302.
- Mellinghoff IK, Penas-Prado M, Peters KB, Burris HA, Maher EA, Janku F, et al. (August 2021). "Vorasidenib, a Dual Inhibitor of Mutant IDH1/2, in Recurrent or Progressive Glioma; Results of a First-in-Human Phase I Trial". Clinical Cancer Research. 27 (16): 4491–4499. doi:10.1158/1078-0432.CCR-21-0611. PMC 8364866. PMID 34078652.
- Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, et al. (August 2023). "Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma". The New England Journal of Medicine. 389 (7): 589–601. doi:10.1056/NEJMoa2304194. PMC 11445763. PMID 37272516.
- Popovici-Muller J, Lemieux RM, Artin E, Saunders JO, Salituro FG, Travins J, et al. (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): 300–305. doi:10.1021/acsmedchemlett.7b00421. PMC 5900343. PMID 29670690.
External links
[edit]- Clinical trial number NCT04164901 for "Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)" at ClinicalTrials.gov
- Clinical trial number NCT02481154 for "Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation" at ClinicalTrials.gov
- Clinical trial number NCT03343197 for "Study of AG-120 and AG-881 in Subjects With Low Grade Glioma" at ClinicalTrials.gov