BRAIN CANCER

The FDA indicated paxalisib's overall survival data could support standard approval in glioblastoma, as supported by GBM-AGILE study findings.

An AI-driven tool enhances stereotactic radiosurgery for small brain metastases by predicting local failure risks, optimizing radiation dosing, and personalizing MRI follow-ups.

Lutetium 177 dotatate showed activity and met the PFS end point in patients with surgery- or radiation-refractory grade 2/3 meningioma, per a phase 2 trial presented at ASTRO 2024.

Sonodynamic therapy doubled the median overall survival to 15.7 months and tripled progression-free survival to 5.5 months in recurrent gliomas, according to a phase 1/2 trial.

MB-108 shows activity and is well tolerated in recurrent glioblastoma, with preclinical data supporting its combination with MB-101 CAR T-cell therapy for improved outcomes.

The FDA accepted the new drug application for TLX101-CDx and granted priority review to the agent in glioma.

The FDA has approved the Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify patients eligible for treatment with vorasidenib.

The agent is currently being evaluated in a phase 1a study, and a phase 1b/2a study will continue to assess LP-184’s safety and efficacy.

Mayra Shanley, PhD, discussed background and future directions for evaluating IL-21 natural killer cells for the treatment of glioblastoma.

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.