BRAIN CANCER

Resection with cesium-131 tile-based radiation therapy prolonged time to surgical bed recurrence vs resection with stereotactic radiation in the phase 3 ROADS trial.

The FDA has approved Pixclara (floretyrosine F 18), the first FET-PET imaging agent for distinguishing recurrent glioma from treatment-related change.

Clark Chen, MD, discusses where tile-based radiation therapy fits within the broader glioblastoma treatment regimen and where the approach may be headed next.

The FDA has granted fast track designation to safusidenib, an oral IDH1 inhibitor, based on durable phase 2 J201 study responses in IDH1-mutant glioma.

NeOnc's intranasal NEO100 met its primary end point in a phase 2a trial of recurrent IDH1-mutant glioma, reaching 48.9% 6-month PFS vs a 20% benchmark.

Phase 2 data show safusidenib drives deepening responses and durable control in IDH1‑mutant grade 2 glioma, prompting new trials for earlier and post‑vorasidenib use.

Adding investigational BPM31510 to standard chemoradiation may boost survival in newly diagnosed glioblastoma, especially MGMT-unmethylated tumors, with promising safety data.

Patient-level analyses suggest DCVax-L boosts glioblastoma survival by up to 6 months, with peer review pending and no randomized control.

Mature 13-year data show radiotherapy and temozolomide yield similar survival in low-grade glioma, but molecular subtype, not treatment order, predicts outcomes.

TRIDENT shows early TTFields with chemoradiation doesn’t boost survival in newly diagnosed glioblastoma, but remains feasible with stable safety.

Glioblastoma treatment still stalls beyond Stupp, while meningioma lacks systemic salvage options; Singh highlights adaptive trials, molecular profiling, and young-patient quality-of-life risks.

Updated NCCN guidelines now recommend CSF-based genomic profiling for biopsy-infeasible high-grade gliomas and glioblastomas, expanding liquid biopsy use in CNS cancer.

The new designation, which adds to an existing orphan drug designation for the same indication, allows for a priority review voucher and other development incentives.

FDA accepted the NDA for 18F-FET, a PET imaging agent designed to distinguish glioma progression from treatment-induced changes in brain cancer.

Researchers work to identify blood-based immune markers, including activated T cells and antibody levels, that may predict long-term survival in patients with glioblastoma.

FDA grants orphan drug designation to rhenium (186Re) obisbemeda for pediatric glioma and ependymoma, supported by the phase 1/2a ReSPECT-PBC clinical trial.

The FDA granted fast track designation to PAS-004, a macrocyclic MEK inhibitor, for NF1-associated plexiform neurofibromas causing significant morbidity.

The FDA granted breakthrough therapy designation to plixorafenib for adult patients with BRAF V600E–mutated high-grade glioma, based on data from a completed phase 1/2a trial and the ongoing phase 2 FORTE basket study.

Phase 2 TBCRC049 trial results show tucatinib triplet therapy improves survival in HER2+ breast cancer patients with leptomeningeal metastasis.

Phase 2b data show RAD101 amino acid PET hits 90% concordance, helping distinguish brain metastasis recurrence from pseudoprogression and necrosis.

FDA grants orphan drug status to irinotecan ChemoSeed implant for high-grade gliomas, enabling sustained local brain tumor therapy and accelerating pivotal trials.