March 22nd 2023
The first orphan drug designation from the FDA has been received by FORE Biotherapeutics and for the FORE8394 program for patients with primary brain and central nervous system malignancies.
February 27th 2023
Hispanic Pediatric Patient With Neuroblastoma Show Worse Overall SurvivalMay 27th 2022
After identifying a survival disparity among non-White Hispanic patients with pediatric neuroblastoma, investigators will next examine the interaction of survival and race, ethnicity, and poverty, acknowledging the intersectionality of these factors due to structural racism in the United States.
Brain Cancer Awareness Month: Advances in the Glioblastoma LandscapeMay 18th 2022
In an interview with Targeted Oncology, Stephen M. Karlovits, MD, discussed key developments that researchers have made in the primary brain tumor treatment landscape in recent years and upcoming trials with potential to improve outcomes for patients.
FDA Receives BLA Resubmission for I-Omburtamab for CNS/Leptomeningeal Metastasis from NeuroblastomaApril 1st 2022
For the second time, an application for approval has been submitted for the FDA for I-omburtamab for the treatment of pediatric patients with central nervous system or leptomeningeal metastasis from neuroblastoma.
Phase 2B Study Explores I/O Vaccine for Treatment of Newly Diagnosed Glioblastoma PatientsFebruary 8th 2022
After treatment with SurVaxM in patients with newly diagnosed glioblastoma significantly improved survival, investigators are continuing the evaluation of the agent in a phase 2b clinical trial.
FDA Updates Clinical Trial Guidelines to Account for CNS MetastasesDecember 14th 2021
The considerations investigators must take into account when designing clinical trials include patient population, previous therapies, assessment of the central nervous system, end points, and leptomeningeal disease, according to the new guidelines.
FDA Grants Fast Track Designation to Silmitasertib for SHH-Driven MedulloblastomaAugust 19th 2021
The FDA has granted fast track designation to the highly selective inhibitor of casein kinase 2 inhibitor, silmitasertib for the treatment of patients with recurrent sonic hedgehog-driven medulloblastoma.
Novel Approaches Optimize Peptide Receptor Radionuclide Therapy for Neuroendocrine TumorsAugust 15th 2021
Rising interest in SSTR2-targeted radiopharmaceuticals has led to the evaluation of numerous ways to optimize peptide receptor radionuclide therapy in patients with neuroendocrine tumors.
Rare Pediatric Disease Designation Granted to DAY101 for Low-Grade GliomaJuly 27th 2021
DAY101, an investigational, oral, brain-penetrant, and highly selective type II pan-RAF kinase inhibitor for the treatment of rare, pediatric low-grade glioma, was granted a rare pediatric disease designation by the FDA.