EMA recommends conditional marketing authorization for belumosudil for cGvHD

On January 30, 2026, the European Medicines Agency (EMA) recommended conditional marketing authorization for belumosudil, a Rho-associated coiled-coil-containing protein kinase 2 (ROCK2) inhibitor, for the treatment of chronic graft-versus-host disease (cGvHD). The recommendation applies to adult and pediatric patients aged ≥12 years (weighing ≥40 kg) whose disease has not been adequately controlled with other therapies, or when other options are unsuitable or exhausted.

The EMA recommendation was supported by clinical data from an open-label study evaluating belumosudil in patients with cGvHD whose disease status was not adequately controlled with corticosteroids plus ≥2 prior systemic therapies. In this study, within 6 months of therapy initiation, 73% of patients achieved an overall response, with 44% maintaining response at 6 months. Complete response (CR) was observed in 5% of patients, while partial response (PR) occurred in 68%. Commonly reported adverse events (AEs) included nausea, diarrhea, fatigue, and elevations in liver enzymes. The Committee for Medicinal Products for Human Use (CHMP) opinion represents an important intermediary step prior to a final decision by the European Commission (EC).