Biopharmaceutical company Deciphera Pharmaceuticals LLC, part of Japan-based Ono Pharmaceutical Co Ltd (TYO:4528), announced on Monday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of ROMVIMZA (vimseltinib) for the treatment of tenosynovial giant cell tumor (TGCT) in adults.

This recommendation applies to patients with symptomatic TGCT associated with impaired physical function where surgery is not viable or would result in unacceptable morbidity. If approved, ROMVIMZA would become the first therapy authorised in the European Union for this indication.

The opinion is based on data from the Phase 3 MOTION trial, in which vimseltinib demonstrated a 40% objective response rate at week 25 versus 0% with placebo, alongside meaningful improvements in range of motion, physical functioning and pain.

Vimseltinib also showed a manageable safety profile consistent with prior Phase 1/2 findings.

A final decision from the European Commission is expected in the second quarter of the fiscal year ending 31 March 2026.