Shots:

• The US FDA has accepted & granted priority review to the BLA for axatilimab, based on the P-II study, as a treatment of chronic GVHD patients failing two prior lines of systemic therapy, with the decision anticipated on Aug 28, 2024
• The P-II (AGAVE-201) study investigates axatilimab’s (0.3mg/kg & 1.0mg/kg, Q2W or 3.0mg/kg, Q4W) safety, efficacy & tolerability in r/r active chronic GVHD adult & pediatric patients (n=241) failing two prior therapies
• The results, featured at ASH’23, demonstrated that the study met 1EPs in all arms, axatilimab (0.3mg/kg, Q2W) attained the highest ORR of 74% in the first 6mos. with a median TTR of 1.7mos. identifying the same as the recommended dose while 60% patients maintained a response at 12mos.

Ref: Incyte | Image: Incyte

Related News:- Syndax and Incyte Report P-II Dose-Ranging Trial (AGAVE-201) of Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

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