Brain Cancer

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.

The FDA has granted fast track designation to the investigational vaccine SurVaxM for the treatment of patients with newly diagnosed glioblastoma.

In a 14-to-6 vote, the FDA’s Oncologic Drugs Advisory Committee voted sufficient evidence has been provided to demonstrate the event-free survival benefit of eflornithine to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma.

The FDA has granted an orphan drug designation to FG001 as an optical imaging agent for the visualization of malignant tissue during surgery for patients with high-grade glioma.

The FDA has granted fast track designation to ABM-1310 for the treatment of patients with glioblastoma harboring BRAF V600E mutations.

The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma. Under Project Renewal, the regulatory agency has also revised indications for the treatment of patients with refractory anaplastic astrocytoma.

A rolling new drug application seeking the approval of tovorafenib monotherapy for the treatment of patients with relapsed or progressive pediatric low-grade glioma has been submitted to the FDA.

Varun Monga, MD, discusses the background for investigating the protein arginine methyltransferase 5 brain-penetrant inhibitor PRT811 in a phase 1 study in patients with recurrent high-grade glioma or uveal melanoma, as well as the agent’s mechanism of action.

The combination of vemurafenib and cobimetinib led to a 94% partial response rate or better in 16 patients with newly diagnosed BRAF-mutated papillary craniopharyngiomas.

Berubicin was found to have acceptable tolerability when administered as second-line treatment in patients with recurrent or refractory glioblastoma multiforme.

The FDA has granted orphan drug designation to LSTA1 for use as a potential therapeutic option in patients with malignant glioma, according to an announcement from Lisata Therapeutics, Inc.

Rimas V. Lukas, MD, reflects on the key points of his presentation delivered at the 2023 Best of ASCO Meeting, which comprised existing unmet needs in low-grade glioma, key efficacy and safety findings from the INDIGO trial, and the viability of vorasidenib-based combination regimens for future investigation.

The FDA has granted an orphan drug designation to ABM-1310 for the treatment of patients with BRAF V600–mutant glioblastoma.

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

The addition of the CXCL12 inhibitor NOX-A12 to standard-of-care radiotherapy and bevacizumab elicited responses when used as first-line treatment in patients with glioblastoma, according to updated data from the expansion arm of the phase 1/2 GLORIA trial.

Varun Monga, MBBS, discusses the mechanism of action of PRT811, key efficacy and safety findings from a phase 1 trial investigating the agent, and potential future directions with this agent in uveal melanoma and IDH-mutant high-grade glioma.

The European Commission has granted an orphan drug designation to Temferon for the treatment of patients with glioma, joining glioblastoma multiforme in its designation.

The addition of the CXCL12 inhibitor NOX-A12 to standard frontline therapy with radiation and bevacizumab led to an overall survival rate of 83% at a median follow-up of 15 months in patients with glioblastoma.

Varun Monga, MD, discusses the investigation of the protein arginine methyltransferase 5 brain-penetrant inhibitor PRT811 in patients with recurrent high-grade glioma or uveal melanoma.