Evidence map›Paper›PMID 42726443›Full record

ArticleDigestive diseases and sciences2026

Vorasidenib-Induced Acute Liver Injury.

Emily A Lau, David R Braxton, Didier Autran, Fengming Chen, Aurelie M Haffner, Jethro Hu, Katherine B Peters, Tse-Ling Fong

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Article in Digestive diseases and sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Emily A LauHoag Memorial Hospital Presbyterian, Hoag Digestive Health Institute, Newport Beach, CA, USA.
David R BraxtonDepartment of Pathology, Hoag Memorial Hospital Presbyterian, Newport Beach, CA, USA.
Didier AutranNeuro-Oncology Department, AP-HM, University Hospital Timone, 13005, Marseille, France.
Fengming ChenDepartment of Pathology, Duke University, Durham, NC, USA.
Aurelie M HaffnerDepartment of Pathology, AP-HM, Aix Marseille University, CHU Timone, Marseille, France.
Jethro HuDivision of Oncology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Katherine B PetersDepartment of Neurosurgery, Duke University Medical Center, Durham, NC, USA.
Tse-Ling FongHoag Memorial Hospital Presbyterian, Hoag Digestive Health Institute, Newport Beach, CA, USA. tseling.fong@hoag.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVorasidenib is a dual inhibitor of isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 used to treat patients with grade 2 astrocytoma or oligodendroglioma with either mutation. Vorasidenib has yet to be linked to cases of acute liver injury.

aimsWe describe 3 cases of severe acute liver injury with features of autoimmune hepatitis associated with vorasidenib and summarize 50 cases of vorasidenib-associated liver injury reported to the FDA.

methodsThis was a case series of 3 patients who developed severe acute liver injury during vorasidenib treatment. A search of the FDA Adverse Event Reporting System database identified 50 cases of suspected drug-induced liver injury from vorasidenib with usable information.

resultsOnset of elevated alanine aminotransferase activities (ALT) were 13, 31, and 2 weeks after vorasidenib initiation. Pattern of liver injury was hepatocellular; mean ALT 1748 U/L, bilirubin level 69.4 μmol/L, and R value 63.9. Despite discontinuation of vorasidenib, ALT continued to increase, and with histology showing centrizonal confluent necrosis, prompted initiation of 40-60 mg prednisone for possible drug induced autoimmune-like hepatitis. ALT normalized and steroids were tapered over 23, 3, and 7 months respectively. Patients remained in remission for 7-25 months after discontinuation of steroids. Among FAERS cases, mean latency to > 3× upper limit of normal ALT was 66 days, 9 were hospitalized, 7 received steroids, and 6 cases with sufficient data met Hy's Law criteria.

conclusionData suggest that vorasidenib-induced liver injury is hepatocellular with a subset that presents with autoimmune-like features which responds to a finite course of corticosteroids.

Indexed as

Autoimmune hepatitisCorticosteroidsDrug-induced liver injuryHepatocellular injuryVorasidenib

Identifiers

PMID42726443

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