The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) of Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals‘ vimseltinib to treat tenosynovial giant cell tumour (TGCT).

Vimseltinib is a colony-stimulating factor 1 receptor (CSF1R).

The review will be carried out under the centralised review process of the European regulator for all 27 member states of the European Union (EU), Iceland, Norway and Liechtenstein.

The MAA filing is based on the findings of the Phase III MOTION clinical trial assessing the safety and efficacy of vimseltinib in people with TGCT not amenable to surgical procedure without previous anti-CSF1/CSF1R therapy, versus placebo.

The study showed a significant objective response rate (ORR) at week 25 – the trial’s primary endpoint – compared to placebo.

Secondary endpoints of the study included ORR per tumour volume score, active range of motion, physical function and quality of life assessments.

Vimseltinib also showed a manageable safety profile with the safety findings from MOTION in line with data reported in the Phase I/II trial of vimseltinib.

Developed using Deciphera’s switch-control kinase inhibitor platform, vimseltinib is an investigational, oral tyrosine kinase inhibitor designed to selectively inhibit CSF1R.

It received orphan drug designation from the EMA in December 2019.

Deciphera Pharmaceuticals president and CEO Steve Hoerter stated: “Building upon positive results from the MOTION pivotal Phase III study, we are excited to initiate the regulatory review process in the EU and we are one step closer in our mission to bring vimseltinib to TGCT patients in need of an effective and well-tolerated treatment.”

https://www.pharmaceutical-technology.com/news/ema-deciphera-maa-review/