The OncLive Brain Cancer condition center page is a comprehensive resource for clinical news and expert insights on various types of brain cancer, including glioma, glioblastoma multiforme, and more. This page features news articles, interviews in written and video format, and podcasts that focus on unmet needs, treatment advances, and ongoing research in brain cancer.
FDA Grants PTC596 Multiple Designations for Leiomyosarcoma, Glioma
November 18, 2020 - The FDA has granted a fast track designation and an orphan drug designation to the orally bioavailable small molecule tubulin-binding agent PTC596 for potential use in patients with leiomyosarcoma; the agent also received a rare pediatric disease designation and an orphan drug designation for potential use in patients with diffuse intrinsic pontine glioma.
FDA Issues Refusal to File Letter for Omburtamab for Pediatric Metastatic Neuroblastoma
The FDA has issued a Refusal to File letter regarding the biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.
ERC1671 Immunotherapy Shows Early Promise in Recurrent Glioblastoma
The investigational immunotherapeutic ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, cyclophosphamide, and bevacizumab showed promising activity in patients with recurrent glioblastoma.
FDA Approval Sought for Omburtamab in Pediatric Metastatic Neuroblastoma
The biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for use in pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been submitted to the FDA under the agency’s Rolling Review process.
Rolling BLA Submitted to FDA for Omburtamab in Pediatric Metastatic Neuroblastoma
A biologics license application has been submitted to the FDA for omburtamab, previously referred to as burtomab, for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.
FDA Grants Naxitamab Priority Review for Relapsed/Refractory High-Risk Neuroblastoma
The FDA has granted a priority review designation to a biologics license application for the investigational, humanized monoclonal antibody naxitamab (Danyelza) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
Chasing a Cure for GBM: Investigators Test Multiple Regimens in Novel Trial
May 14th 2020Investigators of the first global adaptive phase 2/3 GBM Adaptive Global Innovative Learning Environment platform trial are implementing a multiarm, 2-stage approach to concurrently evaluate single-agent and combination regimens in glioblastoma.
INO-5401/INO-9012 Plus Cemiplimab Hits High 6-Month PFS Rate in Newly Diagnosed GBM
November 6th 2019The combination of INO-5401 and INO-9012 with cemiplimab, plus chemoradiation, demonstrated promising 6-month progression-free survival rates in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase methylated or unmethylated.
TOCA 511 and Toca FC Treatment Misses OS Endpoint in Glioma Trial
September 13th 2019Treatment with Toca 511 and Toca FC did not improve overall survival compared with standard therapy in patients with recurrent high-grade glioma undergoing resection, missing the primary endpoint of the phase III Toca 5 trial.
Nivolumab Combo Misses PFS Endpoint in Newly Diagnosed MGMT-Methylated GBM
September 5th 2019The combination of nivolumab plus standard temozolomide and radiation therapy did not show a statistically significant improvement in progression-free survival compared with temozolomide/radiation therapy alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated, missing one of the primary endpoints of the phase III CheckMate-548 trial.
University of Wisconsin Team Develops Novel Strategy for High-Risk Neuroblastoma
June 20th 2019Investigators at the University of Wisconsin American Family Children’s Hospital are developing a new approach to treating patients with neuroblastoma that has the potential to improve outcomes for patients whose disease has not responded to conventional therapy.
Investigators Hope Glioma Trial of Eflornithine Will Clinch Approval
May 24th 2019Eflornithine (α-Difluoromethylornithine) has been investigated for over 30 years as a potential neuro-oncology agent and shown activity against recurrent gliomas, but it has not gained approval as a therapy option for patients with cancer. Investigators are looking to change that with the phase III STELLAR trial (NCT02796261).
Nivolumab/RT Combo Misses OS Endpoint in Newly Diagnosed Glioblastoma Trial
May 10th 2019The combination of nivolumab plus radiation therapy compared with temozolomide did not improve overall survival in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme, missing the coprimary endpoint of the phase III CheckMate-498 trial.