Novel therapy approved by FDA to treat graft-vs-host disease

The U.S. Food and Drug Administration has approved axatilimab-csfr, a colony-stimulating factor-1 receptor-blocking antibody, for the treatment of children and adults weighing at least 40 kilograms with chronic graft-vs-host disease.

Graft-vs-host disease is a condition that occurs when donor immune cells attack tissues in transplant recipients.

The approval came after researchers demonstrated positive results in the AGAVE-201 clinical trial. The researchers enrolled patients with graft-vs-host disease that recurred or didn’t respond to at least two prior lines of systemic therapy.

The patients treated with the recommended axatilimab doses responded well to therapy and had a low rate of death. The most common treatment-related reactions included increased aspartate aminotransferase, infections and decreased hemoglobin, among other adverse events.

Read more: FDA

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