Sanofi’s Rezurock Gets Nod For Treating cGVHD in India

Hyderabad: Sanofi Healthcare India Pvt Limited has received marketing authorisation for Rezurock (Belumosudil tablets) in India for treating chronic graft-versus-host disease (cGVHD) patients globally (12 years and above), after failure of two previous lines of treatment, including those with difficult-to-treat manifestations like fibrosis.

Rezurock was approved by the US FDA (in 2021) and by the CDSCO in India (in 2024) based on safety and efficacy results from ROCKstar – a randomised, open-label, multicentre pivotal trial of the medicine in patients with cGVHD who had received two to five prior lines of systemic therapy.

Administered once daily (orally), Rezurock 200 mg achieved an overall response rate (ORR) of 74 per cent and has shown robust and durable responses across the spectrum of cGVHD.