FOCUS on Drug Approvals. On August 6 the FDA granted accelerated approval to Jazz Pharmaceuticals’ Dordaviprone (TIC10 or ONC-201) for patients with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Dordaviprone is an allosteric activator of mitochondrial caseinolytic protease P (ClpP). This is the first approval by the FDA of a systemic therapy for H3 K27M-mutant diffuse midline glioma.
Dordaviprone was originally discovered as a novel TRAIL Inducing Compound (TIC10). Focus Biomolecules offers Dordaviprone (TIC10 or ONC-201) for research applications.
