The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals’ 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 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.
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It also showed significant improvements in all key secondary endpoints over placebo.
Vimseltinib’s safety profile in the trial has been deemed manageable, with safety data from the MOTION study aligning with earlier Phase I/II clinical trial findings.
The European Medicines Agency (EMA) initiated the centralised review process for vimseltinib, having accepted a Marketing Authorization Application in July this year.
Deciphera Pharmaceuticals CEO and president Steve Hoerter said: “Building upon positive results from the MOTION pivotal Phase III study and following our recent announcement that EMA review of the vimseltinib MAA has begun, we are excited to initiate the regulatory review process in the US and we look forward to working with the FDA to deliver a new treatment option to patients with TGCT.”
In April this year, Ono and Deciphera signed a definitive merger agreement for a deal valued at $2.4bn.
