- In November 2024, Mustang Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-108, a herpes simplex virus type 1 (HSV-1) oncolytic virus, for the treatment of malignant glioma
- In September 2024, Adaptin Bio announced that the FDA had cleared an Investigational New Drug (IND) application for its APTN-101 program in glioblastoma (GBM), the most prevalent and aggressive primary brain tumor. This clearance allows the company to begin a first-in-human Phase 1 clinical trial to assess the investigational candidate's potential in treating GBM
- In August 2024, Servier announced that the U.S. Food and Drug Administration (FDA) has approved VORANIGO, an inhibitor targeting isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2). This treatment is now approved for adult and pediatric patients aged 12 and older with Grade 2 astrocytoma or oligodendroglioma that carry a susceptible IDH1 or IDH2 mutation, following surgery such as biopsy, subtotal resection, or gross total resection. VORANIGO is now available, providing glioma patients with a convenient once-daily pill to actively manage their disease
- In September 2023, AnHeart Therapeutics announced that the first patient had been dosed in the Phase 2 clinical trial, G203, which is assessing the effectiveness of safusidenib in patients with Grades 2 or 3 recurrent or progressive mutant isocitrate dehydrogenase 1 (mIDH1) glioma, a prevalent form of adult primary brain cancer
- In June 2021, SpringWorks Therapeutics, Inc. announced the launch of a Phase 1/2 clinical trial to assess the efficacy of mirdametinib, an experimental MEK inhibitor, in treating children, adolescents, and young adults with low-grade glioma (LGG)
