Press Release: Sanofi's Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease

Core Viewpoint - Sanofi's Rezurock (belumosudil) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for conditional marketing authorization in the EU to treat chronic graft-versus-host disease (GVHD) in adults and children aged 12 years and older with a body weight of at least 40 kg, particularly when other treatment options are limited or exhausted [1][2][7] Group 1: Clinical Efficacy and Safety - The CHMP's recommendation is based on safety and efficacy results from multiple clinical studies, including the ROCKstar phase 2 study, which showed a best overall response rate (ORR) of 74% among patients treated with Rezurock after at least two prior lines of systemic therapy [6][9] - Treatment with Rezurock was generally well tolerated, with common adverse reactions including fatigue (46%), diarrhea (35%), nausea (35%), dyspnea (32%), cough (30%), and upper respiratory tract infections (26%) [9] Group 2: Market Context and Future Steps - Rezurock is already approved in 20 countries, including the US, UK, and Canada, for patients aged 12 years and older who have failed at least two prior lines of systemic therapy, and in China after failure of one prior line [3] - Sanofi is committed to conducting a new post-approval confirmatory study to further investigate Rezurock's efficacy and safety, addressing the limited treatment options available for EU patients with chronic GVHD [2][5] Group 3: Disease Impact - Chronic GVHD is a severe complication following stem cell transplants, affecting up to 50% of patients and leading to significant morbidity and late non-relapse mortality [10] - The disease can severely impact patients' daily lives, limiting activities and imposing an emotional toll, highlighting the need for effective treatment options like Rezurock [2][10]