Brain Cancer

The FDA has granted an orphan drug designation to azeliragon for the treatment of patients with glioblastoma.

Tovorafenib monotherapy generated responses in patients with recurrent or progressive pediatric low-grade glioma.

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors.

The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

The Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, Arizona, is attempting to change the way preclinical studies are developed and conducted to assess the efficacy of drugs for glioblastoma multiforme.

The FDA has issued a complete response letter to the biologics license application seeking the approval of 131I-omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

The FDA has granted an orphan drug designation to AUM302 for the treatment of patients with neuroblastoma.

Autologous tumor lysate-loaded dendritic cell vaccination used in combination with standard-of-care treatment extended overall survival for patients with newly diagnosed glioblastoma as well as those with recurrent disease.

In a 16 to 0 vote, the FDA’s Oncologic Drugs Advisory Committee voted that sufficient evidence has not been provided to conclude that 131I-omburtamab improves overall survival for pediatric patients with central nervous system /leptomeningeal metastases from neuroblastoma.

The FDA has expressed concern about the efficacy of 131I-omburtamab prior to a meeting of the regulatory agency’s ODAC to examine data supporting the BLA seeking the agent’s approval for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

Bevacizumab along with reirradiation extended progression-free survival compared with bevacizumab alone for patients with recurrent glioblastoma multiforme.

Lutetium-177-FAP-2286 produced preliminary evidence of antitumor activity with a manageable safety profile in patients with advanced or metastatic solid tumors, according to data from the phase 1/2 LuMIERE trial.

The FDA has approved bevacizumab-adcd, a bevacizumab biosimilar, for the treatment of six types of cancer.

The European Medicines Agency Committee for Orphan Medical Products has granted an orphan drug designation to CAN-2409 for the treatment of patients with glioma.

Rhenium-186 nanoliposome administered at doses exceeding 100 Gy demonstrated promising safety and efficacy results in patients with recurrent glioma.

The FDA has granted an orphan drug designation to WP1122 as a potential therapeutic option for patients with glioblastoma multiforme.

For the first time, the American Society for Radiation Oncology has issued recommendations on the use of radiation therapy to treat patients with IDH-mutant grade 2 and grade 3 diffuse glioma, including oligodendroglioma and astrocytoma.

The FDA has granted an orphan drug designation to DSP-0390 for the treatment of brain cancer.

The FDA has granted an orphan drug designation to NT-I7 for the treatment of patients with glioblastoma multiforme.

The National Comprehensive Cancer Network issued recommendations for providers treating children with brain cancers.

CV-01, Alpheus Medical’s novel sonodynamic therapy delivery platform, has received orphan drug and fast track designations from the FDA for the treatment of patients with recurrent glioblastoma.

The FDA has granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

The FDA has placed a partial clinical hold on the phase 1/2 NUV-422-02 trial evaluating the selective small molecule CDK2/4/6 inhibitor NUV-422 in patients with solid tumors such as high-grade glioma, hormone receptor–positive advanced breast cancer, and metastatic castration-resistant prostate cancer.

The FDA has granted an orphan drug designation to VBI-1901, a novel cancer immunotherapeutic vaccine candidate, as a potential therapeutic option for patients with glioblastoma.

The FDA has granted an orphan drug designation to paxalisib for use as a potential therapeutic option for patients with atypical rhabdoid and teratoid tumors, a rare and highly aggressive pediatric brain cancer.

The FDA has granted a fast track designation to dianhydrogalactitol for the treatment of patients with newly-diagnosed unmethylated glioblastoma.

The combination of dabrafenib plus trametinib demonstrated a significant improvement in overall response rate, clinical benefit rate, and progression-free survival and fewer grade 3 or greater adverse effects and discontinuations vs carboplatin and vincristine in pediatric patients with low-grade glioma harboring a BRAF V600 mutation.

The combination of the humanized anti-GD2 antibody naxitamab-gqgk, irinotecan, temozolomide, and sargramostim met its primary end point for objective response rate in patients with chemoresistant high-risk neuroblastoma.

Non-White Hispanic children and those with public insurance care in a clinical trial for high-risk neuroblastoma had inferior overall survival rates compared with other children.

Dabrafenib plus trametinib produced clinically meaningful objective responses rates in patients with recurrent or progressive BRAF V600E mutation–positive glioma.