PARIS, France, March 31, 2026
Sanofi has received European Commission approval for Rezurock® (belumosudil) for the treatment of chronic graft-versus-host disease (cGvHD) in patients aged 12 years and older, marking a major advancement in treatment options for patients with limited therapeutic alternatives. The conditional marketing authorization follows a positive opinion from the European Medicines Agency (EMA) and is based on strong clinical evidence demonstrating meaningful and durable responses in patients with refractory disease.
EU Approval Expands Treatment Options for cGvHD Patients
The approval of Rezurock represents a significant milestone in addressing chronic graft-versus-host disease, a life-threatening complication following allogeneic stem cell transplantation. The therapy is indicated for patients who have failed multiple prior lines of systemic treatment or have limited options, highlighting its role in late-line treatment settings where unmet need remains high.
Chronic GvHD affects up to 50% of patients undergoing stem cell transplantation, leading to severe inflammation, fibrosis, and multi-organ damage, significantly impacting patient quality of life and survival. The availability of Rezurock in the EU introduces a new targeted therapeutic option that can help address the significant clinical burden associated with this condition.
The European Commission granted conditional marketing authorization, requiring Sanofi to conduct additional confirmatory studies, ensuring continued evaluation of the therapy’s long-term safety and efficacy. This regulatory pathway is commonly used for innovative treatments addressing serious or rare diseases with high unmet need.
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Clinical Data Demonstrates Strong Efficacy and Safety
The approval is supported by results from the ROCKstar Phase 2 clinical study, a pivotal trial evaluating Rezurock in patients with chronic GvHD who had received two to five prior lines of therapy. The study demonstrated a statistically significant overall response rate (ORR) of 74%, indicating strong efficacy in a heavily pretreated patient population.
In addition to high response rates, the therapy showed durable clinical benefit and a manageable safety profile, with commonly reported adverse events including fatigue, diarrhea, nausea, dyspnea, and respiratory infections. These findings reinforce the drug’s favorable benefit-risk profile, particularly in patients with limited treatment alternatives.
Rezurock is a selective ROCK2 (Rho-associated coiled-coil kinase 2) inhibitor, targeting key pathways involved in immune dysregulation and fibrosis, which are central to the pathophysiology of chronic GvHD. By modulating immune response and reducing tissue damage, the therapy offers a mechanism-driven approach to disease management.
Regulatory Momentum and Global Availability
Rezurock has already been approved in multiple regions, including the United States, United Kingdom, Canada, and China, with more than 20,000 patients treated globally since its first approval in 2021. The EU approval further expands its global footprint and strengthens Sanofi’s position in immunology and transplant-related therapies.
The therapy was previously granted orphan drug designation, reflecting its importance in treating rare and serious conditions. Ongoing clinical studies are evaluating its use in younger pediatric populations and additional indications, including chronic lung allograft dysfunction, highlighting its broader therapeutic potential.
Sanofi continues to invest in advanced immunology research and innovative therapies, leveraging clinical data and regulatory expertise to deliver new treatment options for patients with complex and underserved conditions.
A New Standard for Chronic GvHD Care
The EU approval of Rezurock marks a significant advancement in the treatment landscape for chronic graft-versus-host disease, offering patients a targeted therapy with proven efficacy and safety. As further studies progress, Rezurock is expected to play a critical role in improving outcomes and quality of life for patients facing this challenging condition.
Source: Sanofi press release
