ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025
FDA Approval Summary: Vorasidenib for IDH-Mutant Grade 2 Astrocytoma or Oligodendroglioma Following Surgery.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed.
- Current Treatment Options for Adult Grade 2 IDH-mutant Diffuse Gliomas in the Vorasidenib Era: Patient Selection, Sequencing, and Practical Management.Current treatment options in oncology · 2026Review
- FDA-Approved Drugs Containing Amide Functionality in the Last Five Years (2021-2025): Pharmaceutical Use, Trends and Synthetic Approaches.Medicines (Basel, Switzerland) · 2026Review
- Targeting the cancer metabolism-immunity interface: update and perspectives.Experimental hematology & oncology · 2026Review
- QT Prolongation and Arrhythmias in Cancer Therapy: A Narrative Review of Mechanistic and Clinical Studies.Cardiovascular toxicology · 2026Review
- Development and First-in-Human Translation of Hyperpolarized [1-Sensors (Basel, Switzerland) · 2026Article
- From Epigenetic Constraint to Evolutionary Escape: Cell-State Transitions and Selective Pressures During Malignant Transformation in Lower-Grade Gliomas.Biomedicines · 2026Review
- DNA methyltransferase inhibitors in oncology: clinical progress, limitations and future directions.Epigenomics · 2026Review
- Isocitrate Dehydrogenase-Mutant Astrocytomas: Risk Stratification and Therapeutic Advance.MedComm · 2026Review
- IDH-mutant inhibitors enhance the sensitivity of IDH1-mutant gliomas to cysteine-methionine deprivation and ferroptosis.bioRxiv : the preprint server for biology · 2026Article
- Rational Design, Synthesis and Pharmacological Evaluation of Chalcones as Dual-Acting Compounds-Histamine HInternational journal of molecular sciences · 2026Article
Corrections and comments
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Authors and funding
25 authors.
Funding
Abstract
On August 6, 2024, the FDA granted traditional approval to vorasidenib (Voranigo, Servier Pharmaceuticals, LLC) for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase 1 or 2 mutation following surgery, including biopsy, subtotal resection, or gross total resection. The approval was based on data from a randomized, multicenter, double-blind trial of vorasidenib compared with placebo. The primary objective was to demonstrate the efficacy of vorasidenib based on radiographic progression-free survival (PFS) per blinded independent central review according to the modified Response Assessment for Neuro-oncology for Low-Grade Gliomas criteria. PFS was assessed in 331 patients, and the HR was 0.39 (95% confidence interval, 0.27-0.56; P value < 0.0001). The most common (≥15%) adverse reactions included fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure. PFS was considered an appropriate endpoint for this disease, considering the long natural history and the randomized design allowed for the interpretation of the treatment effect in this rare malignancy. This was the first FDA approval for a targeted therapy for isocitrate dehydrogenase-mutant grade 2 gliomas.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.