Brain Cancer

In case you missed it, below is your guide to the important regulatory approvals made by the FDA in April 2024.

Leland Metheny, MD, discusses how agents such as Iomab-B have potential to shift practice in the hematologic malignancy space.

Vebreltinib has received approval from China’s NMPA in pretreated IDH-mutant, PTPRZ1-MET fusion–positive astrocytoma or glioblastoma.

Sarah E. S. Leary, MD, MS, discusses the FDA approval of tovorafenib for pediatric patients with relapsed/refractory, BRAF-mutant low-grade glioma.

The FDA granted accelerated approval to tovorafenib for pediatric patients relapsed/refractory low-grade glioma with a BRAF fusion/rearrangement or a BRAF V600 mutation.

In case you missed any, below is a recap of every episode of OncLive On Air that aired in March 2024.

The database of the phase 1/2 trial of EO2401 in combination with nivolumab with or without bevacizumab in recurrent glioblastoma has locked.

The PET imaging agent TLX101-CDx has received FDA fast track designation for the characterization of progressive or recurrent glioma.

Early safety and efficacy data seen with AZD1390 in a phase 1 study indicate it's potential utility as a radiosensitizing treatment in glioblastoma.

The cancer vaccine immunotherapeutic VBI-1901 generated disease control in patients with recurrent glioblastoma.

Grant winner Tyler Miller, MD, PhD, outlines innovative plans for glioma research.

Treatment with a next-generation CAR T-cell agent displayed early efficacy in a small group of patients with glioblastoma.

A CAR T-cell therapy directed toward 2 brain tumor–associated proteins displayed preliminary activity in recurrent glioblastoma.

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

CAN-3110, an HSV-1 oncolytic viral immunotherapy candidate, has received FDA fast track designation for adult patients with recurrent high-grade glioma.

The NCCN has published the first set of treatment recommendations for neuroblastoma.

Stephen Bagley, MD, MSCE, discusses the phase 3 ACTION trial evaluating ONC201 in H3K27M-mutant diffuse midline gliomas.

Ashley Sumrall, MD, FACP, medical oncologist, section chief, Neuro-Oncology, clinical assistant professor, medicine, Atrium Health, Levine Cancer Institute, discusses the clinical efficacy of ONC201 in H3K27M-mutant diffuse midline gliomas.

The use of the first-in-class, microbiome-derived therapeutic vaccine EO2401 in combination with nivolumab with or without bevacizumab produced clinical activity and was well tolerated in patients with progressive/recurrent glioblastoma.

The FDA has granted fast track designation to the RNA replacement enzyme–based cancer gene therapy RZ-001 for the treatment of patients with glioblastoma, according to an announcement from Rznomics Inc.

The use of the optical imaging agent FG001 led to the detection of additional cancer by optical guidance in patients with high-grade glioma, meeting the primary end point of the phase 2b FG001-CT-001 trial.

VAL-083 did not improve efficacy compared with standard-of-care approaches in patients with glioblastoma.

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

The FDA has granted an orphan drug designation to TTX101 as a potential therapeutic option for patients with malignant glioma.

The FDA has granted a fast track designation to the dendritic cell vaccine DOC1021 for use as a potential therapeutic option in patients with glioblastoma multiforme.