New Hope for GVHD Patients as Rezurock Wins EU Approval | iPharmaCenter
- Badari Andukuri
- Apr 2
- 2 min read
The European Commission has granted conditional marketing authorisation for Sanofi’s Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD) in adults and adolescents aged 12 years and older who weigh at least 40 kg.
The approval offers a critical treatment option for patients who have limited benefit from current therapies or have exhausted existing options.
The decision is supported by evidence from multiple clinical trials and real-world studies, including the phase 2 ROCKstar trial (NCT03640481). The multicentre, randomised study showed durable and clinically meaningful responses in patients with chronic GVHD who had undergone prior stem cell transplantation and received at least two previous systemic treatments.
Overall, Rezurock exhibited a manageable safety profile.
Sanofi will now undertake a confirmatory randomised controlled trial as part of the conditional approval requirements.
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Rezurock received orphan drug designation in 2019 for treating graft-versus-host disease. The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has confirmed the continued orphan status following the recent authorisation.
Globally, Rezurock is already available in over 20 countries, including the United States, United Kingdom, Canada, and China.
The treatment is approved for patients aged 12 and above with chronic GVHD who have previously failed systemic therapies, two or more in most markets and at least one in China. Since its initial approval in the U.S. in July 2021, more than 20,000 patients with chronic GVHD have been treated with Rezurock worldwide.
About Rezurock (Belumosudil)
Rezurock is a selective inhibitor of ROCK2 (Rho-associated coiled-coil kinase 2). The drug helps manage the immune and fibrotic processes that drive chronic GVHD, offering benefits to patients who have not responded adequately to previous treatment lines.
About the ROCKstar Clinical Trial
The ROCKstar (KD025-213) study was a pivotal phase 2, open-label, randomised, multicentre trial assessing Rezurock’s efficacy and safety in individuals with chronic GVHD who had received two to five prior lines of systemic therapy. Participants received Rezurock 200 mg daily, continued until disease progression or unacceptable toxicity occurred.
The study’s primary endpoint was the best overall response rate (ORR). Rezurock achieved a 74% ORR, demonstrating notable clinical activity. A three-year follow-up study confirmed sustained clinical benefit with manageable safety outcomes.
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