Oncoceutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Oncoceutics’ investigational cancer drug ONC201 for the treatment of adult recurrent H3 K27M-mutant high-grade glioma.

Treatment with ONC201 alone or combined with bevacizumab is well tolerated in patients with recurrent H3 K27M-mutant scDG and a subset of patients experiences prolonged survival that exceeds historical outcomes.

...a now 9-year old patient with thalamic H3K27M-mutant DMG underwent treatment with ONC201 after initial radiation and developed an increase in tumor size at 4 months post-radiation (124% baseline) of unclear etiology at the time. Meanwhile, her ddPCR declined from baseline 6.76% VAF to <1%, which has persisted, with now near complete response (85% tumor reduction) at 30 months on treatment from diagnosis.