Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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
- Belumosudil (Rezurock) is an oral selective inhibitor of Rho-associated coiled-coil-containing protein kinase 2 (ROCK2), which reduces type 17 and follicular T helper cells via downregulation of STAT3 and enhances regulatory T cells via upregulation of STAT5.
- The study was conducted on adult and pediatric patients aged 12 years or older with chronic graft-versus-host disease (cGVHD) who had received two to five prior lines of therapy, indicating that Rezurock may be effective in treating cGVHD after other treatments have failed.
- In a phase 2 randomized multicenter registration trial involving subjects receiving either belumosudil at doses of 200 mg daily or twice daily, the best overall response rate for both dosages were high: 74% for once-daily dosage and 77% for twice-daily dosage- suggesting its effectiveness across different subgroups.
- All affected organs demonstrated complete responses to treatment with Rezurock; moreover, symptom reduction was reported in approximately six out every ten subjects regardless if they took the drug once or twice per day.
- Adverse events associated with belumosudil were consistent with those expected from patients taking corticosteroids and other immunosuppressants; however, only twelve percent discontinued use due to possible drug-related adverse effects implying it has a tolerable safety profile compared to similar drugs used in this patient population.
- This information comes from one document classified as a Randomized Controlled Trial, providing robust evidence supporting the efficacy and safety profile of Belumosudil (Rezurock).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rezurock (belumosudil) Prescribing Information. | 2023 | Kadmon Pharmaceuticals LLC, Warrendale, PA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Belumosudil for chronic graft-versus-host disease (cGVHD) after 2 or more prior lines of therapy: the ROCKstar study. | 132Subjects F: 43% M: 57% | 2021 | Blood |
Document Title
Sex Distribution:
F:43%
M:57%
132Subjects
Year:
2021
Source:Blood