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# Deciphera Pharma Gets OK for Romvimza
- URL: https://www.fdaweb.com/deciphera-pharma-gets-ok-for-romvimza/
- Published: 2025-02-18T12:00:00.000Z
- Updated: 2026-09-14T14:53:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158677

FDA has approved a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. TGCT is a rare, non-malignant tumor that forms within or near joints, according to the company, adding that it arises from the dysregulation and overproduction of the CSF1 gene. “If left untreated or if the tumor repeatedly recurs, it can lead to damage and degeneration in the affected joint and surrounding tissues, potentially causing significant disability,” it says.

Deciphera says approval was based on data from the company’s MOTION study, with the therapy meeting its primary endpoint in the intent-to-treat (ITT) population and demonstrating statistically significant and clinically meaningful improvement versus placebo in the objective response rate (ORR) at week 25\. “In the ITT population, the ORR at Week 25 was 40% (95% CI: 29%, 51%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the placebo arm resulting in a response difference (vimseltinib versus placebo) of 40%,” it adds.