Sanofi’s Rezurock Receives EU CHMP Recommendation for Chronic GVHD Treatment

A promising new treatment for chronic graft-versus-host disease (GVHD) is one step closer to becoming available in Europe. On January 30, 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of Rezurock (belumosudil) for adult and pediatric patients aged 12 years and older weighing at least 40 kg.

What is Rezurock and Why is This Recommendation Significant?

Rezurock is designed for patients with chronic GVHD who have limited options, or whose current treatments are no longer effective. This recommendation follows a request by Sanofi for re-examination of a previous negative opinion issued by the CHMP in October 2025. The European Commission is expected to make a final decision in the coming weeks.

Did You Know? Rezurock has already been approved in 20 countries, including the United States, the United Kingdom, and Canada.

The Impact on Patients

Chronic GVHD can significantly impact a patient’s quality of life, affecting daily activities and causing emotional distress. According to Professor Mohamad Mohty, a hematologist at Hôpital Saint-Antoine and Sorbonne Université in Paris, France, this positive opinion represents an important step forward for patients who have exhausted other treatment options.

Clinical Trial Results

The CHMP’s recommendation is based on data from multiple clinical studies and real-world evidence, including the Phase 2 ROCKstar trial. This trial demonstrated clinically meaningful and durable responses with Rezurock in patients with chronic GVHD who had previously received at least two lines of systemic therapy. The treatment was generally well-tolerated. Sanofi will also conduct a confirmatory randomized controlled study as part of the conditional marketing authorization.

Expert Insight: The re-examination request and subsequent positive opinion from the CHMP highlights the importance of continued data evaluation and the potential for evolving perspectives on emerging therapies, particularly in complex conditions like chronic GVHD where treatment options remain limited.

What Happens Next?

If approved by the European Commission, Rezurock could offer a new therapeutic option for a significant number of patients. Sanofi plans to continue studying the safety and efficacy of Rezurock in other age groups and for different conditions, including pediatric patients and those with chronic allograft dysfunction after lung transplantation. However, these additional indications have not yet been approved by regulatory authorities.

Frequently Asked Questions

What is graft-versus-host disease (GVHD)?

GVHD is a life-threatening complication that can occur after a stem cell transplant when the donor’s cells attack the recipient’s cells, causing inflammation and scarring that can damage multiple tissues and organs.

Who is Rezurock intended for?

Rezurock is intended for adults and children aged 12 years and older weighing at least 40 kg with chronic GVHD who have already tried at least two prior lines of systemic therapy (in some regions, after only one line of therapy).

What were the key findings of the ROCKstar study?

The ROCKstar study showed a 74% overall response rate with Rezurock in patients with chronic GVHD, and the treatment was generally well-tolerated. Common side effects included fatigue, diarrhea, and nausea.

How might new treatment options impact the lives of those living with chronic GVHD?