Nuvation Bio has received FDA Fast Track designation for safusidenib, an investigational oral, brain-penetrant selective inhibitor of mutant IDH1 being developed for patients with IDH1-mutant glioma.
The designation is intended to facilitate development and speed FDA review of therapies for serious conditions with unmet medical needs. It provides for more frequent interactions with the agency during development and may allow a company to submit completed sections of a marketing application for rolling review, rather than wait until the full application is complete.
Nuvation said the Fast Track status could help shorten the time needed to bring safusidenib to patients with IDH1-mutant glioma, a group the company said needs additional treatment options.
Safusidenib is designed to selectively inhibit the mutated form of isocitrate dehydrogenase 1, or IDH1. Nuvation describes the candidate as an oral therapy capable of penetrating the brain.
The FDA granted the designation on the basis of data from the safusidenib clinical program. Most recently, Nuvation released updated results from its Phase 2 J201 study, which evaluated the therapy over longer-term follow-up.
At a median follow-up of 38.8 months, safusidenib produced a confirmed objective response rate of 51.9% in the J201 study. Median progression-free survival had not been reached, while the 36-month progression-free survival rate was 79.1%.
Only one patient who had previously responded to treatment later experienced disease progression, according to the company. Nuvation said no new safety signals were identified during longer-term follow-up and described the treatment’s risk-benefit profile as favorable.
The J201 results build on findings previously published in Neuro-Oncology, Nuvation said.
David Hung, Nuvation’s founder, president and chief executive officer, said the company sought Fast Track designation in an effort to advance the therapy on an expedited timetable.
“People with IDH1-mutant glioma urgently need additional treatment options,” Hung said. He added that Nuvation plans to work with the FDA as it continues development of safusidenib.
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