Brain Cancer

The gamma-delta T-cell therapies INB-400 and INB-410 have received orphan drug designations from the FDA for use as potential therapeutic options in patients with newly diagnosed glioblastoma.

Bently P. Doonan, MD, discusses the evaluation of targeted inhibition of IRAK-4 with emavusertib in the treatment of metastatic brain melanoma.

The FDA has granted a fast track designation to ERAS-801 for the treatment of adult patients with glioblastoma harboring EGFR gene alterations.

Jezabel Rodriguez-Blanco, PhD, discusses unmet needs for pediatric patients with relapsed brain tumors, including the need for additional treatment approaches for these patients.

The combination of PARP and ATR inhibition with olaparib and ceralasertib was tolerable but showed limited efficacy in pediatric patients with advanced malignancies harboring DNA replication stress and DNA repair deficiencies, according to findings from arm N of the phase 1/2 AcSé-ESMART trial.

Priscilla K. Brastianos, MD, explains the differences between low-grade meningiomas and aggressive high-grade tumors.

Nader Sanai, MD, discusses symptoms associated with high-grade meningiomas, a rare brain tumor.

Priscilla K. Brastianos, MD, reviews recent findings in high-grade meningiomas, including data generated in her laboratory.

At present, there are no FDA-approved systemic therapies for patients with high-grade meningiomas. However, there has been an increase in research surrounding the disease over the past decade, which is improving the prospect a targeted agent may become for this population.

The FDA has granted an orphan drug designation to FORE8394 for the treatment of primary brain and central nervous system malignancies.

The FDA has approved dabrafenib with trametinib for the treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.

Vorasidenib monotherapy elicited a statistically significant and clinically meaningful improvement in progression-free survival compared with placebo in patients with residual or recurrent IDH1/2-mutant low-grade glioma.

Given the current lack of positive phase 3 immunotherapy trials for glioblastoma, a misconception held by oncologists and neuro-oncologists is that immunotherapy has no place in this malignancy.

The FDA has granted an orphan drug designation to Temferon for use as a potential therapeutic option in patients with glioblastoma multiforme.

The FDA has granted an orphan drug designation to BEA-17 for the treatment of patients with glioblastoma.

Manmeet Singh Ahluwalia, MD, discusses the evaluation of SurVaxM in combination with oral temozolomide in patients with newly diagnosed glioblastoma.

The FDA has granted an orphan drug designation to azeliragon for the treatment of patients with glioblastoma.

Tovorafenib monotherapy generated responses in patients with recurrent or progressive pediatric low-grade glioma.

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors.

The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

The Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, Arizona, is attempting to change the way preclinical studies are developed and conducted to assess the efficacy of drugs for glioblastoma multiforme.

The FDA has issued a complete response letter to the biologics license application seeking the approval of 131I-omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

The FDA has granted an orphan drug designation to AUM302 for the treatment of patients with neuroblastoma.

Autologous tumor lysate-loaded dendritic cell vaccination used in combination with standard-of-care treatment extended overall survival for patients with newly diagnosed glioblastoma as well as those with recurrent disease.

In a 16 to 0 vote, the FDA’s Oncologic Drugs Advisory Committee voted that sufficient evidence has not been provided to conclude that 131I-omburtamab improves overall survival for pediatric patients with central nervous system /leptomeningeal metastases from neuroblastoma.