Sanofi has announced that its Rezurock (belumosudil) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of adults and adolescents weighing over 40kg with chronic graft-versus-host disease (GVHD).
GVHD is a complication that can follow a stem cell transplant. It happens when donor cells attack the host’s cells and is characterised by inflammation and fibrosis, which can cause tissue and organ damage. Up to half of allogeneic haematopoietic stem cell transplant patients develop chronic GVHD, and it is one of the leading causes of morbidity and late non-relapse mortality following a stem cell transplant. GVHD can seriously impact patients’ quality of life and places strain on healthcare systems.
Rezurock is intended for use in cases where other treatment options are unsuitable, offer limited benefit or have been exhausted.
The CHMP previously expressed a negative opinion of Rezurock in October 2025, but following Sanofi’s request for re-examination, it has now adopted a positive opinion. The European Commission will now come to a decision on whether to grant marketing authorisation for Rezurock.
The positive opinion is based on data from multiple studies, as well as real-world evidence regarding Rezurock. The phase 2 ROCKstar study showed that Rezurock offered durable response to GVHD patients who had already undergone two or more lines of systemic therapy. The study also found that Rezurock was well tolerated. Sanofi also plans to conduct a confirmatory study to support the CHMP’s positive opinion.
Rezurock has already gained various approvals around the world, including in the US, UK and Canada for adults and adolescents after two systemic therapies have failed, and in China after one has failed.
Olivier Charmeil, executive vice president, general medicines at Sanofi, said: “We sought a re-examination of the CHMP opinion, and made the commitment to conduct a new post-approval confirmatory study.”
Professor Mohamad Mohty, professor of haematology, head of the Haematology and Cellular Therapy Department at Hôpital Saint-Antoine and Sorbonne University, Paris, added: “For patients who have exhausted available treatment options, this positive opinion marks an important step forward in our ability to better manage this challenging disease.”