This is a great sign.. This experimental drug, Onc-201 is the first treatment ever that targets diffuse midline glioma and DIPG. Early results look very good. Our organization has given them many grants to try to speed up this process, but getting Rare Pediatric Disease Designation, along with Orphan Drug and Fast Track designation will hopefully allow the FDA to approve it sooner rather than later!
FDA Grants Rare Pediatric Disease Designation to ONC201 for the Treatment of H3 K27M-Mutant Glioma