Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 200 mg) |
Drug Class | Kinase 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.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- 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 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 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