Sanofi’s Rezurock Receives Approval for Chronic Graft-versus-host Disease
Tuesday, March 31, 2026
Sanofi has received conditional marketing authorisation from the European Commission for Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD).
Chronic GVHD is a serious and potentially life-threatening condition that can develop after an allogeneic stem cell transplant. It can affect multiple organs and significantly impact patients’ quality of life. A substantial proportion of patients require third-line treatment, yet available therapies at this stage remain limited in the European Union.
Rezurock is a selective ROCK2 inhibitor designed to address the underlying mechanisms of chronic GVHD. Ongoing studies are evaluating its use in younger paediatric patients and in other conditions, including chronic lung allograft dysfunction. These uses are still under investigation and have not yet received regulatory approval.
The approval applies to adults and children aged 12 years and above with a body weight of at least 40 kg, particularly in cases where existing treatment options have shown limited benefit, are unsuitable, or have been exhausted.
This decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in January 2026. The approval is conditional and requires the completion of a confirmatory randomised, controlled study.
The approval is supported by data from clinical studies and real-world evidence. This includes results from the ROCKstar phase 2 study, which showed meaningful and durable responses in patients who had received at least two prior lines of systemic therapy. The treatment was generally well tolerated.
Under the terms of the conditional approval, Sanofi will conduct an additional confirmatory study to further assess the medicine’s safety and effectiveness.
Rezurock was granted orphan designation in 2019 for the treatment of GVHD. Following the EU approval, the European Medicines Agency’s Committee for Orphan Medicinal Products has supported maintaining this designation.
The medicine is already approved in more than 20 countries, including the United States, the United Kingdom, and Canada for patients aged 12 years and older after failure of at least two prior therapies.
In China, it is approved after failure of one prior therapy. Since its first approval in 2021, more than 20,000 patients have been treated with Rezurock globally.
Source: sanofi.com
