REZUROCK belumosudil

Drug Class

ROCK2 inhibitor

Mechanism

Inhibits Rho-associated coiled-coil kinase 2 (ROCK2), regulating pro-inflammatory Th17 and regulatory Treg cell balance, and downregulating pro-fibrotic signaling.

Approved Indication

Treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.

What This Means For Patients

Rezurock (belumosudil) is a targeted oral kinase inhibitor approved by the FDA and NMPA for chronic graft-versus-host disease (cGVHD). It helps regulate the immune response and reduce tissue scarring (fibrosis) in patients who have not responded to other systemic treatments. Eligible patients can access the treatment in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2021) — label
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• ROCKstar — Cutler et al., Blood 2021 (NCT03640481) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214701s000lbl.pdf
• https://www.nmpa.gov.cn/