EU approves Sanofi's Rezurock for chronic graft-versus-host disease

The European Commission has issued a conditional marketing authorization for Sanofi’s Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD). The drug is indicated for adults and children 12 years and older weighing at least 40 kg, specifically for cases where existing therapies have proven insufficient or unsuitable.

Regulatory approval follows findings from several clinical trials, including the phase 2 ROCKstar study, which indicated durable responses in patients who had previously failed at least two lines of systemic therapy. As part of the conditional authorization, Sanofi is required to conduct a confirmatory, randomized, controlled trial to further validate these clinical outcomes.

Chronic GVHD remains a significant complication for patients following allogeneic stem cell transplantation. With nearly 50% of patients requiring third-line treatment, the availability of new therapeutic options has been a critical industry focus. Rezurock, which holds orphan drug designation, is already available in 20 countries, including the U.S. and U.K., and Sanofi continues to investigate its efficacy in pediatric populations and other indications.