NIKTIMVO for the Treatment of cGvHD, US - Clinical Trials Arena
NIKTIMVO™ (axatilimab), a first-in-class anti-CSF-1R antibody, treats chronic graft-versus-host disease (cGvHD) in adults and pediatric patients weighing ≥40kg with at least two failed systemic therapies. FDA approved in August 2024, NIKTIMVO targets inflammation and fibrosis drivers in cGvHD, supplied as a 50mg/ml solution in single-dose vials for IV administration. Clinical trial AGAVE-201 showed 75% ORR within six months, with sustained response in 60% at 12 months.
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NIKTIMVO™ (axatilimab), a first-in-class anti-CSF-1R antibody, treats chronic graft-versus-host disease (cGvHD) in adults and pediatric patients weighing ≥40kg with at least two failed systemic therapies. FDA approved in August 2024, NIKTIMVO targets inflammation and fibrosis drivers in cGvHD, supplied as a 50mg/ml solution in single-dose vials for IV administration. Clinical trial AGAVE-201 showed 75% ORR within six months, with sustained response in 60% at 12 months.
Niktimvo™ (axatilimab-csfr) met primary endpoint in AGAVE-201 trial, showing 74% response rate in 0.3 mg/kg dose cohort for chronic graft-versus-host disease (GVHD). FDA approved Niktimvo for GVHD treatment after two prior therapies, and it's added to NCCN Guidelines as a category 2A recommendation.