Express inhibits inflammation and fibrosis, FDA today approved the first ROCK2 inhibitor

▎The content team editor of WuXi AppTec today, Kadmon announced that the US FDA approved the company’s Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (cGVHD) patients over 12 years old.
These patients have received two Early systemic treatment
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The press release pointed out that Rezurock is the first ROCK2 inhibitor approved by the FDA, and ROCK2-mediated signaling pathways play an important role in regulating inflammation and fibrosis
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Hematopoietic stem cell transplantation is a common treatment for blood or bone marrow cancer
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However, in patients with cGVHD, the transplanted immune cells will attack the host's healthy cells, causing a series of serious side effects
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It is estimated that about 30%-70% of patients undergoing hematopoietic stem cell transplantation will develop symptoms of cGVHD, including inflammation and multi-organ tissue fibrosis
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As a ROCK2 kinase inhibitor, belumosudil can reduce the phosphorylation of STAT3 and strengthen the phosphorylation of STAT5, thereby down-regulating over-activated T helper cells (Th17) and enhancing the function of regulatory T cells (Treg), thereby rebuilding immune balance
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The FDA previously granted belumosudil breakthrough therapy designation and orphan drug designation for the treatment of cGVHD patients
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Its new drug application has also obtained priority review qualifications, and is reviewed under the FDA's Real-time Oncology Review (RTOR) and the Orbis pilot project
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▲ Diagram of the mechanism of action of Belumosudil (picture source: reference [2]) FDA approval is based on the results of a random, open-label, multi-center pivotal clinical trial called ROCKstar
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A total of 65 patients received Rezurock's treatment.
The trial results showed that Rezurock achieved an overall response rate (ORR) of 75% and a complete response rate of 6%
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The median time to first remission was 1.
8 months
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62% of patients who achieved remission did not need to use new systemic therapies for at least 12 months after remission
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The median duration of remission (defined as the time from first remission to disease progression, death, or the need for new systemic treatment) was 1.
9 months
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"Rezurock is a new treatment model for thousands of cGVHD patients
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" said Dr.
Corey Cutler, associate professor of Harvard University School of Medicine.
"It has shown strong and lasting relief in many types of cGVHD patients, and it has good results.
The safety and tolerability of the drug allows patients to continue to receive treatment and obtain meaningful benefits
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"Reference: [1] US FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD).
Retrieved July 16, 2021, from https://investors.
kadmon.
com/news-releases/news-release-details/us-fda-grants-full-approval-rezurocktm-belumosudil-treatment[2] Kadmon Corporate Presentation.
Retrieved July 16, 2021, from https://investors.
kadmon .
com/static-files/a9d862ce-b6cb-4cd6-b368-6182271b3d58 Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
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If you need treatment plan guidance, please go to a regular hospital
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