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Incyte Reports the US FDA’s Acceptance of BLA for Axatilimab with Priority Review to Treat Chronic Graft-Versus-Host Disease (GVHD)

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Incyte Reports the US FDA’s Acceptance of BLA for Axatilimab with Priority Review to Treat Chronic Graft-Versus-Host Disease (GVHD)

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  • 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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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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