Sanofi’s Rezurock recommended for EU approval to treat chronic graft-versus-host disease
Monday, March 30, 2026
Sanofi has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, recommending conditional marketing authorisation of Rezurock in the European Union.
The treatment is intended for adults and children aged 12 years and older, weighing at least 40 kg, who have chronic graft-versus-host disease (GVHD). It is proposed for use in cases where other treatment options offer limited benefit, are unsuitable, or have already been used.
The recommendation follows a re-examination request by Sanofi after a previous negative opinion issued in October 2025. A final decision from the European Commission is expected in the coming weeks.
Chronic GVHD is a complex condition that can affect multiple organs and significantly impact patients’ daily lives. The CHMP’s positive opinion represents progress in expanding treatment options for patients with limited alternatives.
The recommendation is supported by data from clinical studies and real-world evidence, including the ROCKstar Phase 2 trial. The study showed meaningful and sustained responses in patients with chronic GVHD following stem cell transplant and at least two prior systemic treatments. The therapy was generally well tolerated.
As part of the conditional approval, Sanofi will carry out an additional randomised controlled study to confirm the treatment’s clinical benefit.
Rezurock is already approved in several countries, including the United States, the United Kingdom, and Canada for patients aged 12 years and older after failure of at least two prior systemic therapies. In China, it is approved after failure of one prior line of treatment.
More than 17,000 patients with chronic GVHD have been treated with Rezurock globally since its first approval in 2021.
Source: sanofi.com
