Brain Cancer

The FDA has granted FTD and cleared an IND application for daretabart, an anti-GD2 monoclonal antibody, for the treatment of high-risk neuroblastoma.

The FDA has set a Prescription Drug User Fee Act date of September 11, 2026, for TLX101-Px for patients with brain cancer.

Treatment with Rhenium-186 Obisbemeda for pediatric malignant gliomas and ependymomas is being assessed in the ReSPECT-PBC trial.

Results from a phase 1/2a trial and the ongoing FORTE basket study support the FDA’s regulatory decision for these patients with recurrent or progressive glioma.

The FDA has cleared an investigator-initiated investigational new drug application for a first-in-class AAV immuno-gene therapy in recurrent high-grade glioma.

FG001 is an investigational uPAR-targeting fluorophore designed to provide real-time illumination of aggressive brain tumors during surgical resection.

The irinotecan-based ChemoSeed delivery mechanism is currently under investigation for patients with malignant glioma in a registrational phase 2 trial.

The updated NDA submitted to the FDA included additional data and statistical analyses from existing clinical trials for pediatric and adult patients with glioma.

SRN-101, an AAV-based immuno-gene therapy, has received fast track designation for the treatment of recurrent high-grade glioma.

The FDA has cleared an IND application for FG001, allowing the developer to initiate its first US registration trial in patients with high-grade glioma.

Charlotte Ivey Rivers, MD, discussed the importance of rare CNS tumor research, upcoming trial data in meningioma, and the role of functional radiosurgery.

Findings from a phase 2 study demonstrate the feasibility of conducting genomically driven trials among patients with meningiomas.

The developer now plans to initiate a first-in-human clinical trial among patients with recurrent high-grade glioma.

Researchers have found that engineering CAR T cells to target Tenascin-C, an extracellular matrix protein enriched in glioblastoma, can shrink tumors and prolong survival in preclinical brain tumor models while sparing healthy tissue.

With a median follow-up of 6 months, the median OS was not yet reached in patients with recurrent glioblastoma with the nogapendekin alfa inbakicept-based regimen.

The submission of an investigational new drug application for a uPAR-targeted imaging agent, FG001, supports a planned phase 2 trial in glioma.

Among the 12 patients with suspected brain metastases treated with RAD 101, the images showed metabolic activity in brain metastases compared with MRI findings.

Treatment with IGV-001 demonstrated a 45% increase in overall survival compared with standard of care in patients with newly diagnosed glioblastoma.

Edward Chu, MD, a member of the gastrointestinal editorial advisory board, died of glioblastoma in November.

One patient with newly diagnosed glioblastoma multiforme reached 3 years of survival following treatment with temferon in a phase 1/2a trial.

Data from a phase 1 trial demonstrate the safety and feasibility of administering chlorotoxin-based cellular therapy to those with recurrent glioblastoma.

While more work must be done to minimize toxicity, antibody-drug conjugates have demonstrated benefits for patients with glioblastoma.

Interim data from the phase 1b CLOVER-2 trial evaluating iopofosine I 131 in children and adults with high-grade glioma supported the FDA’s decision.

The evaluation of MT-125’s safety and preliminary activity in glioblastoma is underway in a phase 1/2 trial.