Kadmon bags a quick win for its graft-versus-host disease drug ahead of August PDUFA date
About a year and a half after Kadmon trumpeted “knock-your-socks-off” results for its chronic graft-versus-host disease (GVHD) treatment, the FDA has followed through with a speedy approval six weeks before the agency was supposed to announce a decision.
The FDA has approved Rezurock (belumosudil) as a third-line treatment in adult and pediatric patients 12 years and older, based on pivotal results from the ROCKstar trial showing a 75% overall response rate and a 69% partial response rate.
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