Belumosudil

(Rezurock®)

Rezurock®

Drug updated on 5/17/2024

Dosage FormTablet (oral; 200 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

Summary
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  • Belumosudil (Rezurock) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
  • A study from a Phase 2 randomized multicenter registration study evaluated the efficacy and safety profile of belumosudil in treating cGVHD.
  • The patient population included subjects who had received between 2 to 5 prior lines of systemic therapy, indicating resistance or inadequate response to existing treatments. High response rates were observed across all subgroups suggesting broad effectiveness within this demographic.
  • Efficacy results showed high overall response rates: 74% for the daily dose regimen and 77% for twice-daily dosing. This indicates a strong therapeutic effect on treated patients. Additionally, symptom reduction was reported in over half the subjects, highlighting significant quality-of-life improvement.
  • Safety evaluation revealed that adverse events were consistent with expectations for this patient group; no additional risks beyond those associated with other cGVHD treatments seem apparent from using belumosudil. Only twelve percent discontinued due to possible drug-related adverse events, implying relatively favorable tolerability given the challenging treatment landscape of cGVHD.
  • Based on its demonstrated high efficacy across various patient subgroups along with a manageable safety profile, belumosudil could offer an effective alternative especially when previous therapies have failed.

Product Monograph / Prescribing Information

Document TitleYearSource
Rezurock (belumosudil) Prescribing Information.2023Kadmon Pharmaceuticals LLC, Warrendale, PA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study.
132Subjects
F: 43%
M: 57%
2021Blood

Sex Distribution:

F:43%
M:57%
132Subjects

Year:

2021

Source:Blood