Kadmon Acquires FDA Approval For Belumosudil

Chronic Graft-Versus-Host Disease Gets a New Treatment: Belumosudil

  • Belumosudil got FDA Approval on July 16, 2021, to treat Chronic Graft-Versus-Host Disease (chronic GVHD).
  • Eligible patients must be aged at least 12 years and have received two prior systemic therapies.

Patients suffering from Chronic Graft-Versus-Host Disease now have an efficacious treatment option, Belumosudil. On 16th July 2021, US FDA (Food and Drug Administration) approved Belumosudil (marketed by Kadmon Pharmaceuticals LLC under the brand name Rezurock) for the treatment of those patients with Chronic Graft-Versus-Host Disease who are at least aged 12 years of age and have received two prior therapies (systemic treatments).

The efficacy of Belumosudil was evaluated and established in an open-label, randomized multicenter dose-ranging clinical trial namely KD025-213 (NCT03640481) that consisted of 65 patients suffering from chronic GVHD. The patients were treated using Belumosudil with a fixed strength of 200 mg once daily (orally). 

The major efficacy outcome measure was ORR (overall response rate) of the drug through Day 1 of the 7th Cycle in which ORR included CR (complete response) and PR (partial response) as per the clinical trial criteria 2014 by NIH Consensus Development Project. Besides that, the most common side effects included hypertension, gamma-glutamyltransferase increased, headache, abdominal pain, edema, asthenia, infections, nausea, diarrhea, dyspnea, cough, hemorrhage, musculoskeletal pain, decrease in phosphate, and decrease in lymphocytes.

Moreover, the recommended dose of Belumosudil (Rezurock) is 200 mg once daily with food (oral administration).

Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a condition that occurs in certain patients who have gone through an allogeneic stem cell transplant. A stem cell transplant is a surgical procedure that uses the healthy blood stems of a donor to replace the deceased bone marrow of a patient. After this procedure, if the donated bone marrow views the body as foreign or suspicious, it attacks the body. This causes chronic GVHD with symptoms like skin rash, abdominal swelling, mouth ulcer, and skin tightening among others.

Belumosudil

Belumosudil is a serine/threonine kinase inhibitor, a formulation that inhibits the activity of certain proteins responsible for certain diseases. As per the recent FDA approval, it is 

prescribed for the treatment of patients suffering from Chronic Graft-Versus-Host Disease, who have been previously treated with at least two therapies and are aged above 12 years.

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