BRAIN CANCER

Christopher Moertel, MD, discussed findings from the phase 2 ReNeu trial of mirdametinib in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

A new drug application for TLX101-CDx, an investigational PET imaging agent designed to differentiate progressive or recurrent glioma from treatment-related changes, has been submitted to the FDA.

Data from the phase 2 ReNeu study presented at the 2024 ASCO Annual Meeting support this priority review designation.

The innovative bispecific antibody INV724 targets GD2 and B7-H3 with high specificity for neuroblastoma.

The study will evaluate silmitasertib, a novel agent, for the treatment of pediatric and adult patients with relapsed/refractory solid tumors.

In an interview, Timothy F. Cloughesy, MD, discussed the recent approval of vorasidenib in IDH-mutant gliomas and data from the phase 3 INDIGO trial.

The FDA has granted approval to vorasidenib for the treatment of patients with IDH-mutant diffuse glioma.

The FDA has granted expanded access to TLX101-CDx, a promising PET imaging agent for diagnosing and monitoring glioma.

The FDA has granted a fast track designation to AGuIX, a gadolinium-based nanodrug currently under evaluation for treating malignant gliomas and glioblastoma.

In an interview with Targeted Oncology for Brain Cancer Awareness Month, Theodore Schwartz, MD, discussed the challenges of targeting brain tumors, emerging therapies, and strategies to overcome the blood-brain barrier.

The FDA has approved the new drug application of tovorafenib for the treatment of pediatric low-grade glioma.

The FDA granted a fast track designation to olaptesed pegol with bevacizumab and radiotherapy for patients with newly diagnosed glioblastoma that is resistant to chemotherapy and where measurable tumor remains after surgery.

Findings from the phase 3 METIS trial found that tumor-treating fields were able to significantly improve time to intracranial progression in patients with brain metastases from non-small cell lung cancer.

A novel CAR T-cell therapy being developed at City of Hope offers a potential new treatment avenue for patients with recurrent glioblastoma and high-grade glioma. 

The FDA approved the investigational new drug application for olaptesed pegol as a potential treatment for adult patients with aggressive brain cancer, specifically glioblastoma.

The FDA has accepted and granted priority review for the new drug application for vorasidenib for the treatment of IDH-mutant diffuse glioma, with a PDUFA action date set for August 20, 2024.

Combining olaptesed pegol with bevacizumab and radiotherapy showed a 10-fold improvement in survival rate compared with the standard-of-care among patients with glioblastoma.

The FDA completed an advice meeting with the manufacturer of olaptesed pegol in anticipation of the filing of an investigational new drug application in Q1 of 2024.

A Safe to Proceed letter from the FDA has been granted to the investigational new drug application of a phase 2 study evaluating ropidoxuridine plus radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma.

The completion of the phase 1 trial is a crucial step toward making DOC1021 available to all patients with glioblastoma multiforme.

The median overall survival at 19 months of patients with glioblastoma continues to benefit from treatment with olaptesed pegol plus radiation and bevacizumab.

In an interview with Targeted Oncology, Yazmin Odia, MD, discussed the 3rd Annual Miami Cancer Institute Oncology Rehabilitation Symposium, including her discussion on incorporating rehabilitation into the course of treatment for patients with brain cancer.

The FDA has approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma.

VBI-1901 10µg plus GM-CSF had a disease control rate of 44% among 16 patients with recurrent glioblastoma in a phase 1/2a study.

Results from a phase 1/2a trial showed that plixorafenib had potential regarding safety and efficacy in BRAF-mutated solid tumors, especially in primary central nervous system tumors.

The combination of olaptesed pegol, bevacizumab, and radiotherapy showed an improvement in overall survival among patients with glioblastoma, according to findings from a phase 1/2 study.

The fast track designation granted to SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device from the FDA is for the treatment of patients with diffuse intrinsic pontine glioma.

A phase 1/2 trial is evaluating the safety, efficacy, and tolerability of RZ-001 in patients with glioblastoma.

THIO has received 2 prior orphan drug designations, and the agent has shown promise in preclinical studies for the treatment of glioblastoma.

The FDA accepted the new drug application and granted priority review to tovorafenib with a Prescription Drug User Fee Act target date of April 30, 2024.