FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy

Last Updated: Monday, August 15, 2022

The U.S. Food and Drug Administration (FDA) recently approved belumosudil (Rezurock) a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD after failure of at least two prior lines of systemic therapy based on the results of Study KD025-213. Additional study is warranted to confirm safety in long-term use.

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FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy

Pediatric Blood & Cancer

Prophylactic donor lymphocyte infusion after haploidentical hematopoietic cell transplantation and post-transplant cyclophosphamide for treatment of high-risk myeloid neoplasms in children: A retrospective study

Bone Marrow Transplantation

Acute GVHD classification based on the dynamics of GVHD skin involvement from its appearance to the start of systemic treatment

Regulatory Focus

FDA guidance explores trial design, supporting data for GVHD treatments

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