Shots:
- The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision is expected in Q3’25
- Opinion 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 of improved ORR (40% vs 0%) in ITT pts, plus showed improvements across active range of motion, patient-reported physical functioning, & pain observed at 25wks., with favorable safety as depicted by P-I/II data
Ref: Ono Pharma| Image: Deciphera Pharmaceuticals | Press Release
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