Astrocytoma
Recent clinical, regulatory, research and industry developments relating to this disease.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 1 regulatory approval from EMA on record.
- 6 clinical trials expected to report results, the earliest in Q4 2026.
- Active recent publication activity.
- Q4 2026A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
- Q4 2026An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
- Q4 2030A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
- Q2 2033Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination With the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 Astrocytomas
- Q2 2035Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma
Research HighlightsViewHide
- 2025-11-01FDA Approval Summary: Vorasidenib for IDH-Mutant Grade 2 Astrocytoma or Oligodendroglioma Following Surgery.Barbato MI · 2025
Clinical MilestonesViewHide
- 2026-07-24A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)Results expected Q4 2030
- 2026-07-07An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)Results expected Q4 2026
- 2026-07-02A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 MutationsResults expected Q4 2026
- 2026-07-02Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination With the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 AstrocytomasResults expected Q2 2033
- 2026-05-22Vorasidenib as Maintenance Treatment After First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: a Placebo-controlled, Triple-blind, Randomized Phase III Study (VIGOR)Results expected Q2 2035
Regulatory UpdatesViewHide
- 2025-09-17Approval — VorasidenibVoranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).
- 2030-11-30ClinicalA Phase II/III Randomized, Open-Label Study of Toca 511, A Retroviral Replicating Vector, Combined With Toca FC With Temozolomide and Radiation Followed by Adjuvant Temozolomide and Toca FC Compared to Temozolomide and Radiation Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed GlioblastomaWithdrawn
- 2026-07-24ClinicalA Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)Results expected Q4 2030
- 2026-07-07ClinicalAn Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)Results expected Q4 2026
- 2026-07-02ClinicalA Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 MutationsResults expected Q4 2026
- 2026-07-02ClinicalPhase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination With the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 AstrocytomasResults expected Q2 2033
- 2026-05-22ClinicalVorasidenib as Maintenance Treatment After First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: a Placebo-controlled, Triple-blind, Randomized Phase III Study (VIGOR)Results expected Q2 2035
- 2026-04-13ClinicalPhase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic OligoastrocytomaResults expected Q2 2035
- 2025-11-12ClinicalNeuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral ChemotherapyCompleted
- 2025-11-01ResearchFDA Approval Summary: Vorasidenib for IDH-Mutant Grade 2 Astrocytoma or Oligodendroglioma Following Surgery.Barbato MI · 2025
- 2025-09-17RegulatoryApproval — VorasidenibVoranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Gra… (2025)
Approval — Carmustine is indicated n adults in the following malignant neoplasms as a single ag… (2018)
Approval — Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicate… (2011)
Approval — Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed… (2011)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Astrocytoma2
- Brain Neoplasms2
- Mutation2
- Central Nervous System Neoplasms1
- Glioma1
- Isocitrate Dehydrogenase1
- Oligodendroglioma1
- Triazines1
Leading journals5
- Acta neuropathologica communications1
- Clinical cancer research : an official journal of the American Association for Cancer Research1
- Genes & development1
- Journal of the National Comprehensive Cancer Network : JNCCN1
- The New England journal of medicine1
Leading researchers8
- Ahluwalia M1
- Ananthula S1
- Aungst SL1
- Bachoo RM1
- Baehring J1
- Barbato MI1
- Barone AK1
- Batinic-Haberle I1
Affiliations (unnormalised)6
- 10Roswell Park Comprehensive Cancer Center.1
- 11Moffitt Cancer Center.1
- 12UC San Diego Moores Cancer Center.1
- 13Robert H. Lurie Comprehensive Cancer Center of Northwestern University.1
- 14University of Michigan Rogel Cancer Center.1
- 15Memorial Sloan Kettering Cancer Center.1
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Astrocytoma is a neoplasm of the brain and spinal cord derived from glial cells. It ranges from histologically benign forms to highly anaplastic and malignant tumors, with fibrillary astrocytomas being the most common type. These tumors are classified in increasing order of malignancy from grades I through IV, and their typical location varies by age.
The supplied grounding does not support a specific external cause or aetiology for astrocytoma. It does indicate that the disease is associated with genetic alterations, including changes involving isocitrate dehydrogenase in the literature. For malignant astrocytic gliomas, the literature emphasizes underlying genetics and biology rather than a single known cause.
Astrocytomas arise from glial cells and can progress from lower-grade to highly malignant disease. Malignant astrocytic gliomas are characterized by widespread invasion throughout the brain, destruction of normal brain tissue, and resistance to traditional and newer targeted therapies. The literature also highlights genetic and signaling abnormalities, including isocitrate dehydrogenase-related changes, as part of the disease biology.
The grounding does not provide established risk factors for astrocytoma. It does note age-related patterns of origin, with tumors in the first two decades of life tending to arise in the cerebellar hemispheres and adult tumors more often arising in the cerebrum. In pediatric low-grade glioma, incomplete surgical resection is associated with repeat progression and morbidity, but this is a factor in clinical course rather than a proven risk factor for developing the disease.
Management is described at the level of surgery, therapy, and drug therapy. The literature supports surgical treatment and, for some tumors, targeted therapeutics aimed at molecular pathways such as RAS/MAPK, particularly in pediatric low-grade glioma. For malignant astrocytic gliomas, treatment remains challenging because of therapeutic resistance, and the literature points to ongoing development of novel therapies rather than a single definitive standard drug class.
AI-generated summary grounded in MeSH and 2 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
Neoplasms of the brain and spinal cord derived from glial cells which vary from histologically benign forms to highly anaplastic and malignant tumors. Fibrillary astrocytomas are the most common type and may be classified in order of increasing malignancy (grades I through IV). In the first two decades of life, astrocytomas tend to originate in the cerebellar hemispheres; in adults, they most frequently arise in the cerebrum and frequently undergo malignant transformation. (From Devita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2013-7; Holland et al., Cancer Medicine, 3d ed, p1082)
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.