Voranigo (vorasidenib) / Servier, Royalty - LARVOL DELTA

Royalty Receipts was $856 million in the fourth quarter of 2025, an increase of 17% compared to $729 million in the fourth quarter of 2024. (The Manila Times) - "The increase was primarily driven by Voranigo, Trelegy, Tremfya and the cystic fibrosis franchise, which was partially offset by a decline from Promacta due to U.S. generic competition which launched in May 2025."

Commercial • Aplastic Anemia • Asthma • Astrocytoma • Chronic Obstructive Pulmonary Disease • Crohn's disease • Cystic Fibrosis • Glioma • Immune Thrombocytopenic Purpura • Immunology • Oligodendroglioma • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Multicenter Implementation of the German Compassionate Use Program Vorasidenib in IDH-Mutant Glioma: Feasibility and Early Outcomes (DKK 2026) - No abstract available

Clinical • Late-breaking abstract • Brain Cancer • Glioma • Solid Tumor

Isocitrate Dehydrogenase Inhibitors in Acute Myeloid Leukemia. (PubMed, Chem Biodivers) - "Inhibitors of mutated IDH1 and IDH2, vorasidenib, ivosidenib, olutasidenib, and enasidenib, respectively, were recently approved by the FDA for relapsed/refractory AML. In this review, we mainly focus on IDH inhibitors in leukemia therapy, including the discovery, structure optimization, activity of IDH inhibitors, and applications, which provided the reference for the discovery of new anticancer agents."

Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IDH1 • IDH2

Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications. (PubMed, Curr Ther Res Clin Exp) - "Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters...Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index. Mechanistic DDI..."

Clinical data • FDA event • Journal • NDA • PK/PD data • Review • CYP1A2 • CYP2C9

VIGOR: Vorasidenib Maintenance for IDH Mutant Astrocytoma (clinicaltrials.gov) - P3 | N=468 | Recruiting | Sponsor: European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting ➔ Recruiting

Enrollment open • Astrocytoma • Brain Cancer • Oncology • Solid Tumor • IDH1 • IDH2

18F-DOPA-PET and advanced MRI improve treatment response assessment in IDH1/2-mutant gliomas treated with IDH inhibitors. (PubMed, Clin Cancer Res) - "These results highlight the potential of ¹⁸F-DOPA-PET and advanced MRI sequences as valuable complements to standard RANO 2.0 MRI evaluations for assessing treatment response in glioma patients undergoing IDHi therapy."

Journal • Astrocytoma • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor • IDH1 • IDH2

Reasons driving choice and clinical course of patients with CNS WHO grade 3 IDH mutant glioma receiving vorasidenib after surgery: a pilot experience. (PubMed, J Neurooncol) - No abstract available

Journal • Astrocytoma • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor

INDIGO: A global, randomized, double-blinded, phase 3 study of vorasidenib versus placebo in patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation. (ASCO 2023) - P3 | "This is the first prospective, randomized phase 3 study of a targeted therapy in grade 2 mIDH glioma. VOR significantly improved PFS by BIRC compared with PBO with a manageable safety profile. These data demonstrate the clinical benefit of VOR in this pt population for whom chemotherapy and radiotherapy are being delayed."

Clinical • Late-breaking abstract • P3 data • Astrocytoma • Brain Cancer • CNS Tumor • Fatigue • Glioma • Infectious Disease • Novel Coronavirus Disease • Oligodendroglioma • Oncology • Pain • Solid Tumor • IDH1 • IDH2

Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. (PubMed, N Engl J Med) - P3 | "In patients with grade 2 IDH-mutant glioma, vorasidenib significantly improved progression-free survival and delayed the time to the next intervention. (Funded by Servier; INDIGO ClinicalTrials.gov number, NCT04164901.)."

Journal • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor • IDH1 • IDH2

[VIRTUAL] Vorasidenib (VOR; AG-881), an inhibitor of mutant IDH1 and IDH2, in patients (pts) with recurrent/progressive glioma: Updated results from the phase I non-enhancing glioma population. (ASCO 2020) - P1, P3 | "In this previously treated population with non-enhancing glioma, VOR was associated with a favorable safety profile. The study results also show encouraging preliminary activity within that population, with PFS duration extending to 24 months or longer in 60% of participants. A global randomized phase 3 study of VOR in grade 2 non-enhancing glioma pts who have had surgery only is currently enrolling (NCT04164901)."

Clinical • P1 data • Brain Cancer • CNS Disorders • Epilepsy • Fatigue • Glioma • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • IDH1 • MRI

Korea approves Voranigo to treat IDH‑mutant glioma (Chosun Biz) - "The drug was approved in two dose strengths, 10 mg and 40 mg. It is used for patients age 12 or older and weighing 40 kg or more who have residual tumor after surgery and have grade 2 astrocytoma or oligodendroglioma with mutations in the IDH 1 or IDH 2 enzymes."

Korea approval • Astrocytoma • Glioma • Oligodendroglioma

Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation (clinicaltrials.gov) - P3 | N=57 | Active, not recruiting | Sponsor: Servier | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2031 ➔ Oct 2030 | Trial primary completion date: Jun 2026 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor • IDH1 • IDH2

Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.) | Recruiting ➔ Completed

Trial completion • Breast Cancer • Oncology • Solid Tumor

Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma (clinicaltrials.gov) - P1/2 | N=51 | Active, not recruiting | Sponsor: Institut de Recherches Internationales Servier | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor • ATRX • CDKN2A • CDKN2B • IDH1 • IDH2

Reproductive health considerations for IDH-mutant glioma patients considering IDH inhibitor therapy: A retrospective cohort study. (PubMed, Neurooncol Pract) - "According to our institutional data, conversations regarding IDHi reproductive risks are not generally documented, contrary to guideline recommendations. Future studies are required to better understand the impact of IDHi therapy on fertility and fetal development."

Journal • Retrospective data • Brain Cancer • Glioma • Oncology • Solid Tumor

Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma (clinicaltrials.gov) - P1/2 | N=55 | Recruiting | Sponsor: Institut de Recherches Internationales Servier | N=42 ➔ 55

Enrollment change • Brain Cancer • Glioma • Oncology • Solid Tumor

Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)

New P2 trial • Astrocytoma • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Pediatrics • Solid Tumor • IGF1

"Vorasidenib and Low-Grade Glioma: INDIGO Incremental Insights". (PubMed, Neuro Oncol) - No abstract available

Journal • Brain Cancer • Glioma • Oncology • Solid Tumor

Vorasidenib as monotherapy in grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation (PubMed, Bull Cancer) - No abstract available

Journal • Monotherapy • Astrocytoma • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor • IDH1 • IDH2

Comparing Isocitrate Dehydrogenase Inhibitors with Procarbazine, Lomustine, and Vincristine Chemotherapy for Oligodendrogliomas. (PubMed, Cancers (Basel)) - "IDH inhibitors such as vorasidenib have demonstrated promising efficacy and more favorable tolerability profiles, but a paucity of comparative data across therapeutic classes limits optimal treatment decision-making. Prospective head-to-head trials are essential for defining the optimal therapeutic sequence in this evolving treatment landscape. In the interim, we provide a recommend approach for current use."

Journal • Review • Brain Cancer • Glioma • Hematological Disorders • Oligodendroglioma • Oncology • Solid Tumor

Identifying metabolic vulnerabilities of recurrent IDH1-R132H mutant glioma by high throughput screening (SNO 2025) - "Notable target pathways include folate metabolism and de novo thymidylate synthesis (methotrexate, raltitrexed, 5-FU), p97 AAA ATPase/VCP chaperone (CB-5083, ML240, eeyarestatin I), mevalonate pathway (Ro 48-8071 fumarate, atorvastatin calcium), and the BCL-2 family (Navitoclax, ABT-737). We are validating these drugs across a panel of patient-derived IDH-mutant gliomasphere models, and examining the combinatorial effects of these agents with vorasidenib and CDK4/6 inhibitors. Our results provide insight into important metabolic pathway dependencies in recurrent IDH1-R132H mutant gliomas that have targeting potential."

IO biomarker • Brain Cancer • Glioma • Oligodendroglioma • Solid Tumor • BCL2 • IDH1 • NAMPT

Servier India secures CDSCO approval for Vorasidenib for Grade 2 IDH-mutant glioma (ExpressPharma) - "The oral therapy is approved for adults and paediatric patients aged 12 years and older with Grade 2 gliomas, including astrocytoma or oligodendroglioma, with an IDH1 or IDH2 mutation following surgery, which includes biopsy, subtotal resection, or gross total resection."

Approval • Astrocytoma • Oligodendroglioma

VIOLETA: Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: iOMEDICO AG | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioma • Oncology • Solid Tumor

Real-world use of IDH inhibitors in a Broad IDH-mutant Glioma Population (SNO 2025) - "Patients were treated with vorasidenib (n = 21), ivosidenib (n=14), or enasidenib (n=1). Clinical utility of IDHi in patients with higher grade IDHm gliomas, enhancing disease, and prior chemoradiation has not been well-studied. This retrospective analysis illustrates real-world outcomes, suggesting IDHi treatment may be considered for a broader range of IDHm gliomas. Adverse events are common but well-tolerated."

Clinical • Real-world • Real-world evidence • Brain Cancer • Glioma • Solid Tumor

Real-world use of IDH inhibitors in a Broad IDH-mutant Glioma Population (WFNOS 2025) - "Patients were treated with vorasidenib (n = 21), ivosidenib (n=14), or enasidenib (n=1). Clinical utility of IDHi in patients with higher grade IDHm gliomas, enhancing disease, and prior chemoradiation has not been well-studied. This retrospective analysis illustrates real-world outcomes, suggesting IDHi treatment may be considered for a broader range of IDHm gliomas. Adverse events are common but well-tolerated."

Clinical • Real-world • Real-world evidence • Brain Cancer • Glioma • Solid Tumor