The European Commission has granted conditional marketing authorization for Sanofi’s Rezurock (belumosudil), a selective ROCK2 inhibitor, to treat chronic graft-versus-host disease in patients aged 12 and older weighing at least 40 kg. The approval applies when other treatments offer limited benefit or are unsuitable.
The authorization is based on data from the ROCKstar Phase 2 clinical trial, which demonstrated a 74% response rate. As a condition of the authorization, Sanofi must complete a confirmatory randomized controlled study. Professor Mohamad Mohty of Hopital Saint-Antoine noted that “chronic GVHD imposes profound physical and emotional burdens” on transplant recipients.
Rezurock is already approved in 20 countries including the U.S., UK, and Canada, with over 20,000 patients treated since its initial approval in July 2021. The EU authorization expands access to a treatment option for transplant patients suffering from this debilitating complication.