WALTHAM, Mass.– Ono Pharmaceutical Co., Ltd. today announced that the European Commission has approved ROMVIMZA™ (vimseltinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) in the European Union. The approval covers patients whose condition is associated with clinically relevant physical function deterioration and for whom surgical options have been exhausted or would cause unacceptable morbidity or disability. ROMVIMZA is the first and only therapy to receive marketing authorization for TGCT in the EU.
“The European Commission’s approval of vimseltinib for TGCT is a significant milestone for Deciphera, Ono, and TGCT patients across the European Union who are in need of a non-invasive treatment option,” said Ryota Udagawa, President and Chief Executive Officer of Deciphera. “We are excited to leverage our global commercial infrastructure to bring vimseltinib to these patients. We look forward to working with health authorities to ensure all eligible patients who can benefit from vimseltinib have access as quickly as possible.”
Jean-Yves Blay, M.D., Ph.D., of the Leon Berard Center, said the approval represents a turning point. “This is welcome news for the TGCT community as vimseltinib is now the first approved therapy for TGCT in Europe. TGCT can significantly impact the daily lives of patients by causing pain, stiffness, and mobility limitations. Vimseltinib is a differentiated treatment that has demonstrated the ability to address these unmet patient needs while remaining well-tolerated.”
The EC’s decision was based on results from the pivotal Phase 3 MOTION study, which compared vimseltinib with placebo in TGCT patients who were not amenable to surgery and had not received prior anti-CSF1/CSF1R therapy. The study showed statistically significant and clinically meaningful improvements in active range of motion, patient-reported physical functioning, and pain at Week 25. Additional endpoints also demonstrated benefits, including tumor volume response, stiffness, and quality of life.
In a descriptive analysis at Week 97, 23 percent of patients treated with vimseltinib achieved a complete response, with a median time to response of 11.5 months. The safety profile was consistent with earlier clinical results, and the therapy was generally manageable for patients.
With this approval, Deciphera and Ono are preparing to make ROMVIMZA available across Europe, working with regulators and health systems to expand access to patients in need.
