Launch
FDA approves axatilimab-csfr for chronic graft-versus-host disease
What's New: Drugs RSS Feed · By FDA ·
The Brief
- On August 14, 2024, the FDA approved axatilimab-csfr (Niktimvo, Incyte Corporation) for chronic graft-versus-host disease (cGVHD).
- The approval covers cGVHD patients who have failed at least two prior lines of systemic therapy.
- Axatilimab is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody.
Why it matters
It adds a targeted antibody option for chronic GVHD, a serious complication after allogeneic stem cell transplantation, for patients whose earlier treatments have not worked.
Who’s affected
- Patients with chronic graft-versus-host disease after failure of at least two prior lines of therapy
- Transplant and hematology clinicians treating cGVHD
- #fda approval
- #graft-versus-host disease
- #transplantation
- #monoclonal antibody
- #csf-1r
- #hematology
On August 14, 2024, the Food and Drug Administration approved axatilimab-csfr (Niktimvo, Incyte Corporation), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of…
Timeline
FDA approves axatilimab-csfr (Niktimvo) for chronic graft-versus-host disease
What's New: Drugs RSS Feed
FDA approves axatilimab-csfr for chronic graft-versus-host disease