The European Commission (EC) has granted conditional marketing authorization for Sanofi’s Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD). The approval covers adults and pediatric patients aged 12 and older (weighing at least 40 kg) who have exhausted previous systemic therapies.
Disease Impact and Therapeutic Role:
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Life-threatening Complication: GVHD occurs after stem cell transplants when donor cells attack the recipient’s tissues, leading to inflammation, fibrosis, and organ damage. It remains a primary cause of long-term morbidity and non-relapse mortality post-transplant.
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Clinical Efficacy: Rezurock is intended as a late-line intervention. Results from the Phase II ROCKstar study demonstrated durable and clinically meaningful responses in patients who had failed at least two prior lines of systemic treatment.
Regulatory Context and Future Steps: Prior to this EU milestone, Rezurock had already treated over 20,000 patients across 20 countries, including the U.S., UK, and China. As part of the conditional approval mandate, Sanofi will conduct a confirmatory randomized controlled trial to further validate the drug’s profile. This approval addresses a significant unmet need, as nearly half of chronic GVHD patients eventually require third-line therapy due to limited existing options.