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On July 16, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of belumosudil (200 mg once daily) for the treatment of adults and pediatric patients ≥12 years with chronic graft-versus-host disease (cGvHD) who have failed ≥2 prior lines of systemic therapy.1 The approval was based on the results of the phase II ROCKstar trial, which were previously published on the GvHD Hub.
Belumosudil was shown to be efficacious, with robust and durable responses, and was well tolerated. This approval makes belumosudil the first and only ROCK2 inhibitor to be approved in the U.S. and therefore represents a new treatment paradigm for patients with cGvHD, including those with difficult-to-treat manifestations like fibrosis.
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