Deciphera B V — Romvimza EMA EPAR public assessment report (EMEA/H/C/006363, 2025)
Deciphera B V · 2025 · EMA EPAR public assessment report
Report summary
Deciphera B.V. received a positive CHMP opinion in July 2025 for Romvimza (vimseltinib) to treat adult patients with symptomatic tenosynovial giant cell tumour (TGCT) not amenable to surgery. Preclinical studies showed selective CSF1R inhibition and identified organ-specific toxicities. Clinical trials, including the pivotal Phase III MOTION study, demonstrated significant objective response rates and improved range of motion compared to placebo. Common adverse events included oedema and rash, with some Grade 3/4 events and dose modifications. Safety concerns include hepatotoxicity, muscle injury, nephrotoxicity, and skin reactions. Long-term safety data is limited, necessitating post-marketing surveillance.
Key findings — cited to the page
| any TEAE with maximum Grade 3/4 | 37.3 % | MOTION double-blind period, vimseltinib arm · p.124 |
| any TEAE with maximum Grade 3/4 | 37.3 % | MOTION double-blind period, vimseltinib arm · p.127 |
| ORR by IRR using RECIST v1.1 in TGCT Cohort A (entire treatment period) | 64.4 % | · p.115 |
| ORR per RECIST v1.1 at Week 25 by blinded IRR in ITT (placebo arm) | 0 % | · p.119 |
| any drug-related TEAE with maximum Grade 3/4 | 30.1 % | MOTION double-blind period, vimseltinib arm · p.124 |
| any drug-related TEAE with maximum Grade 3/4 | 2.6 % | MOTION double-blind period, placebo arm · p.124 |
| urticaria (Grade 3) | 1.1 % | Pool 1 · p.131 |
| ORR by IRR using RECIST v1.1 at Week 25 (C7D1) in TGCT (no prior anti-CSF1/CSF1R therapy) | 37.8 % | · p.115 |
| ORR based on BOR by IRR using RECIST v1.1 for all TGCT participants | 62.1 % | · p.115 |
| ORR per RECIST v1.1 at Week 25 by blinded IRR in ITT (vimseltinib arm) | 39.8 % | · p.119 |
| any TEAE with maximum Grade 3/4 | 10.3 % | MOTION double-blind period, placebo arm · p.124 |
| any TEAE with maximum Grade 3/4 | 10.3 % | MOTION double-blind period, placebo arm · p.127 |
Source: Deciphera B V ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →