MHRA has approved Romvimza (vimseltinib ) for patients with tenosynovial giant cell tumour
The MHRA has approved Romvimza (vimseltinib ) to treat adult patients with tenosynovial giant cell tumour (TGCT) when it impacts movement or where surgery is not an option.
TGCT (Giant cell tumour of tendon sheath) is a rare, locally aggressive neoplasm, in which overexpression of colony-stimulating factor 1 (CSF1) drives recruitment of macrophages, which results in local inflammation and joint destruction. Patients with TGCT often experience debilitating symptoms, with significant disease burden, and an unmet need for treatment options remains for those whose tumours are not amenable to surgery.
The product registration is supported by compelling efficacy and safety results from the pivotal Phase III MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase I/II study of vimseltinib. In MOTION, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by blinded independent radiologic review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). The primary endpoint was supported by statistically significant and clinically meaningful improvements in active range of motion, patient-reported physical functioning, and patient-reported pain observed in the vimseltinib arm compared to the placebo arm at week 25. The safety profile of vimseltinib is manageable and consistent as demonstrated in the Phase I/II clinical trial.
