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July 16, 2021FDA Approves First-in-Class Treatment for Chronic Graft-Versus-Host Disease
July 16, 2021 – The U.S. FDA has approved RezurockTM (belumosudil), manufactured by Kadmon Holdings, to treat chronic graft-versus-host disease (cGVHD) in patients at least 12 years old who have failed at least two prior lines of systemic therapy.
Graft-versus-host disease (GVHD) is a complication of allogenic stem cell transplants (when a donor’s healthy stem cells are used to replace unhealthy bone marrow). It can be used to treat conditions such as leukemia, lymphoma, plasma cell disorders, aplastic anemia, and many others. GVHD can be either chronic or acute and occurs when the donated cells begin attacking healthy cells in the recipient’s body, mistaking them for foreign material that requires an immune response. Acute GVHD typically occurs within 100 days of the transplant, while cGVHD can occur at any time after the transplant, sometimes years later. Both types of GHVD can range in severity from mild to life-threatening. Rezurock works to treat cGVHD by inhibiting the activity of the ROCK2 signaling pathway that helps control inflammatory responses in the body. It is the first ROCK2 inhibitor to receive FDA approval.
In a clinical trial, Rezurock delivered an overall response rate of 75%. Just over half (52%) of patients had a clinically meaningful improvement from baseline in cGVHD symptoms as measured by the Lee Symptom Scale. Of patients who responded to Rezurock therapy, 62% did not require new systemic therapy for at least one year after response.
Recommended dosing is one 200mg tablet taken by mouth with food once a day until cGVHD progresses to the point of requiring new systemic therapy.
Kadmon has launched Rezurock at a wholesale acquisition cost (WAC) of $15,500 per 30 tablets.