Vimseltinib is intended to treat tenosynovial giant cell tumour. Credit: crystal light / Shutterstock.

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).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

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

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”