Shots:
- The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity
- Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)
- The P-III trial met its 1EP, plus showed improvements across all 2EPs incl. ORR per TVS, active ROM, physical function, stiffness, QoL & pain at 25wks., while in a descriptive analysis at 97wks., 19/83 pts achieved CR per RECIST v1.1, with median time to CR of 11.5mos.
Ref: Ono Pharma| Image: Deciphera Pharmaceuticals | Press Release
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