FDA Approves Niktimvo for Chronic Graft-Versus-Host Disease

The FDA has approved axatilimab-csfr (Niktimvo, Incyte Corporation) for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing 40 kg or more. Axatilimab-csfr is a colony-stimulating factor-1 receptor-blocking antibody.

Efficacy was evaluated in AGAVE-201 (ClinicalTrials.gov. Identifier: NCT04710576), a multicenter, randomized, open-label trial investigating three dosages of axatilimab-csfr