The European Commission has approved ROMVIMZA (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumour (TGCT) in the EU. The decision marks the first marketing authorisation for a TGCT therapy in Europe.
Vimseltinib is indicated for patients with physical function deterioration where surgery is not viable or would cause unacceptable harm. The approval was announced by Ono Pharmaceutical and Deciphera, who jointly developed the treatment.
Ryota Udagawa, CEO of Deciphera, said: “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. We are excited to leverage our global commercial infrastructure to bring vimseltinib to these patients.”
Jean-Yves Blay, Leon Berard Center, added: “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 decision is based on data from the pivotal phase 3 MOTION study and the phase 1/2 trial. Patients treated with vimseltinib showed statistically significant improvements in range of motion, physical function and pain compared to placebo at week 25.
Secondary endpoints also showed benefit across six measures including tumour response, stiffness and quality of life. At week 97, 23% of patients receiving vimseltinib achieved complete response, with a median time to response of 11.5 months.
The safety profile was consistent with earlier trials and considered manageable. Full prescribing information is available in the Summary of Product Characteristics.
