First Drug Approved to Treat Glioma Subtype
The FDA today granted accelerated approval to dordaviprone (Modeyso; Jazz Pharmaceuticals), a protease activator and dopamine receptor blocker for patients age 1 and older with glioma harboring the H3K27M mutation. Among 50 patients across five clinical trials who received the drug, the overall response rate was 22% and the median duration of response was 10.3 months. The H3K27M mutation is found in approximately 80% of pediatric diffuse midline gliomas and in up to 60% of adult diffuse gliomas.
