The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for subsidiary ’ vimseltinib, a treatment for tenosynovial giant cell tumours (TGCTs). Vimseltinib, designed to hinder the colony-stimulating factor 1 receptor (CSF1R), is a product of Deciphera’s switch-control kinase inhibitor platform. The gold standard of business intelligence.
The US regulator set a Prescription Drug User Fee Act goal date of 17 February 2025. The FDA’s decision is underpinned by results from the Phase III MOTION study, a two-part, randomised, double-blind, placebo-controlled trial. It assessed vimseltinib’s efficacy and safety in patients with TGCT not amenable to surgery and without prior anti-CSF1/CSF1R therapy, except for imatinib or nilotinib.
At week 25, the asset offered a statistically significant and clinically meaningful objective response rate in the intent-to-treat population versus placebo. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form It also showed significant improvements in all key secondary endpoints over placebo.
Vimseltinib’s safety profile in the trial has been deemed manageable,.