Deciphera Pharmaceuticals, and Ono Pharmaceutical Co. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of vimseltinib or ROMVIMZA for the treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.
The European Commission decision on Deciphera's marketing authorization application for vimseltinib is expected in the second quarter of the fiscal year ending March 31, 2026.
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