U.S. Food and Drug Administration Approves Belumosudil (REZUROCK) for Chronic Graft-Versus-Host Disease

On July 16, 2021, the U.S. Food and Drug Administration (FDA) announced it has approved the use of belumosudil (REZUROCK, Kadmon Pharmaceuticals, LLC), A kinase inhibitor, for chronic graft-versus-host disease (chronic GVHD) in adult and pediatric patients 12 years and older after the failure of at least two prior lines of systemic therapy.

Graft versus host disease (GVHD) is a condition that might occur after an allogeneic transplant (donor bone marrow or stem cells). In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign, and the donated cells/bone marrow attack the body. There are two types of GVHD: acute and chronic.

The FDA granted this application priority review. A description of the FDA expedited programs can be found here.

“The approval for belumosudil is an important advancement for patients diagnosed with chronic graft-versus-host disease,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation.  “This serious condition previously had limited treatment options, and this approval represents a new reason for hope for patients.”

For more information on this FDA approval visit the FDA’s website.

Learn About: Stem Cell Transplantation

The ability to transplant stem cells allows physicians to use higher doses of chemotherapy to treat the cancer than the body would normally tolerate, increasing the probability of killing cancer cells. If the chemotherapy is followed by an infusion of stem cells, these new stem cells can replace the cells in the bone marrow that were destroyed during the chemotherapy treatment. Read more >