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# Kadmon Pharma’s Rezurock Approved by FDA
- URL: https://www.fdaweb.com/kadmon-pharmas-rezurock-approved-by-fda/
- Published: 2021-07-16T12:00:00.000Z
- Updated: 2026-09-14T17:06:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149731

FDA has approved a Kadmon Pharmaceuticals NDA for Rezurock (belumosudil), a kinase inhibitor for treating adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. Approval was based on data from KD025-213 (NCT03640481), a 65-patient clinical trial. Data showed a 75% overall response rate, with 6% having a complete response and 69% a partial response, according to an [FDA release](http://FDA has approved a Kadmon Pharmaceuticals NDA for Rezurock %28belumosudil%29, a kinase inhibitor for treating adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. Approval was based on data from KD025-213 %28NCT03640481%29, a 65-patient clinical trial. %28XXX SUBSTITUTE PERIOD FOR COMMA XXX%29 Data showed a 75% overall response rate, with 6% having a complete response and 69% a partial response, according to an FDA release. %28XXX INSERT LINK XXX%29     The agency says that the most common adverse reactions observed in the trial were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension).

The agency says that the most common adverse reactions observed in the trial were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.