VIOLETA (IOM-120529) is a multicenter, prospective, non-interventional study evaluating the real-world effectiveness, safety, and patient-reported outcomes of vorasidenib (Voranigo®) in adult patients with non-enhancing WHO grade 2 IDH1- or IDH2-mutant astrocytoma or oligodendroglioma in Germany. Eligible patients have undergone surgery as their sole prior treatment modality and have no immediate indication for adjuvant radiotherapy or systemic therapy. Vorasidenib is an orally bioavailable, brain-penetrant dual inhibitor of mutant IDH1/2 (40 mg once daily), approved on the basis of the pivotal phase 3 INDIGO trial (NCT04164901). Key outcomes of interest include health-related quality of life, seizure burden, and tolerability under routine care conditions. The study is currently enrolling at multiple sites across Germany.
VIOLETA is a German observational study evaluating how vorasidenib (Voranigo®) performs in routine clinical practice. Adults with a low-grade brain tumor – specifically a WHO grade 2 diffuse glioma carrying an IDH1 or IDH2 mutation – who have been treated with surgery alone and currently do not require radiation or chemotherapy are eligible to participate. Vorasidenib is an oral tablet taken once daily that specifically targets the altered IDH enzyme caused by the tumor's genetic change. The study focuses on quality of life, seizure control, and tolerability in everyday clinical settings. It is being conducted at multiple centers across Germany and is currently enrolling patients.
