BRAIN CANCER

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.

Preclinical data of MB-109 from the American Association for Cancer Research Annual Meeting in 2022 support MB-109 as a potential treatment for patients with recurrent glioblastoma.

TTX101 will be studied in a phase 1/2a clinical trial for patients with recurrent glioblastoma.

Results from the phase 1 EQUILIBRIUM study signal better outcomes for patients with newly diagnosed, MGMT methylated glioblastoma.

A fast track designation has been granted to DOC1021 by the FDA for the treatment of patients with glioblastoma multiforme.

In an interview with Targeted Oncology, Rupesh Kotecha, MD, discusses the background of this phase 1 study and current options for patients with brain metastases.

A prospective, multicenter trial continues to recruit patients with brain metastases to evaluate the real-world and patient-reported outcomes of surgically targeted radiation therapy.

The CXCL 12 inhibitor delivered a 50% overall survival rate at 18 months in the GLORIA trial, and its manufacturer intends to seek FDA guidance on further trial design.

Top-line results from a phase 2b trial evaluating FG001 for patients with high-grade glioma are expected by the end of November.

Further development of 177Lu-satoreotide tetraxetan is expected after promising data from a phase 1/2 trial were recently published.

ABM-1310 is an investigational small molecule BRAF inhibitor that is being development for the treatment of various BRAF V600E-mutant solid tumors.

Results from the phase 3 NETTER-2 study will be presented at an upcoming medical conference and shared with drug regulators.

Responses from the FDA regarding questions submitted for a Type B pre-investigational new drug application meeting have provided a pathway for the start of a phase 2 trial of ropidoxuridine in glioblastoma.

Data from the phase 2 FIREFLY-1 trial support the new drug application for tovorafenib in relapsed or progressive pediatric low-grade glioma. The regulatory agency anticipates filing the application by mid-November 2023

Experts believe VAL-083 has the potential to change the way oncologists treat glioblastoma in the future.

Patients treated with VT1021 for recurrent glioblastoma were found to have immune markers associated with response to treatment in a phase 1/2 study.

Identifying alterations to tailor treatment is important for patients with pediatric low-grade glioma as it accounts for one-third of all pediatric central nervous system tumors.

ABM-1310 is a novel small molecule BRAF inhibitor that has shown promising anti-cancer activity and a good safety profile across a variety of advanced BRAF V600-mutant solid tumors.