FDA approves axatilimab-csfr for chronic graft versus host disease

FDA

14 August 2024 - Today, the FDA approved axatilimab-csfr (Niktimvo, Incyte), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft versus host disease after failure of at least two prior lines of systemic therapy in adult and paediatric patients weighing at least 40 kg.

Efficacy was evaluated in AGAVE-201, a randomised, open-label, multi-centre trial investigating 3 dosages of axatilimab-csfr in adult and paediatric patients with recurrent or refractory cGVHD who had received at least 2 lines of systemic therapy and required additional treatment.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US