The European Commission has granted a conditional marketing authorisation for Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD) in adults and children aged 12 and older weighing at least 40 kg. 

 

The drug is approved for patients when other treatments provide limited benefit, are unsuitable, or have been exhausted. The approval is contingent on completion of a confirmatory, randomized, controlled study and follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued on 30 January 2026.

 

“Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation. Across the EU, many patients continue to face significant challenges in managing this disease, particularly when existing therapies fail to provide adequate benefit,” said Mohamad Mohty, Professor of Haematology at Hôpital Saint-Antoine and Sorbonne University, Paris. 

 

"This approval represents an important advance, offering a new therapeutic option that has the potential to meaningfully improve the lives of patients.”

 

“Nearly one in two patients with chronic GVHD require third-line treatment, yet therapeutic options available for EU patients at this late stage of the disease have remained limited,” said Olivier Charmeil, Executive Vice President, General Medicines, and Interim CEO of Sanofi. 

 

“We have an ongoing commitment to supporting patients with chronic GVHD and their caregivers and are pleased to deliver this new treatment option to patients living with this debilitating and long-term condition.”

 

The approval is supported by clinical and real-world evidence, including the multicenter ROCKstar phase 2 study (NCT03640481), which showed clinically meaningful and durable responses in patients with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy. Treatment was generally well tolerated. Under the conditional marketing authorisation, Sanofi will conduct a new confirmatory randomized study.

 

Rezurock was designated an orphan medicine in 2019 for the treatment of GVHD. The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has now confirmed maintenance of its orphan designation.

 

The drug is already approved in 20 countries, including the US, UK, Canada, and China, for patients 12 and older with chronic GVHD who have failed at least one or two prior therapies. Since its first US approval in July 2021, more than 20,000 patients have been treated with Rezurock.