Global oncology company Nuvation Bio Inc (NYSE:NUVB) announced on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1.

In the United States, nearly 2,500 people are diagnosed with IDH-mutant gliomas each year, of which more than 95% harbour a mutation in the IDH1 gene.

FDA Fast Track Designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and address unmet medical need. The designation provides for more frequent interactions with the FDA throughout a drug's development. If relevant criteria are met, the designation may allow for rolling review of a marketing application, permitting completed sections to be submitted for FDA review as they become available, rather than waiting for the entire application to be complete. These benefits have the potential to shorten the time it takes to bring safusidenib to patients.

According to Nuvation, Fast Track Designation was granted based on favourable data from the safusidenib clinical programme to date. Most recently, the company reported updated data from the Phase 2 J201 study demonstrating durable responses and a favourable risk-benefit profile over long-term follow-up. At a median follow-up of 38.8 months in the J201 study, treatment with safusidenib showed a confirmed objective response rate (cORR) of 51.9%, with median progression-free survival (PFS) not yet reached and a 36-month PFS rate of 79.1%, and only one patient who had previously responded experienced subsequent disease progression. No new safety signals have been identified with longer-term follow-up.

These results build on findings previously published in Neuro-Oncology.