Axatilimab: First Approval.

Drugs

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Published: November 2024

AI Article Synopsis

  • * In August 2024, Axatilimab received approval in the USA for treating cGVHD in patients who have not responded to at least two prior systemic therapies, applicable to both adults and children over 40 kg.
  • * The article reviews the key milestones in the development of Axatilimab leading to its first approval for cGVHD treatment.

Article Abstract

Axatilimab (NIKTIMVO™; axatilimab-csfr), an anti-colony-stimulating Factor 1 Receptor (CSF-1R) humanized IgG4 (κ light chain) monoclonal antibody, is being developed by Incyte Corporation and Syndax Pharmaceuticals for the treatment of chronic graft-versus-host disease (cGVHD) and other indications, including idiopathic pulmonary fibrosis (IPF). In August 2024, axatilimab was approved in the USA for the treatment of cGVHD after failure of at least two prior lines of systemic therapy in adult and paediatric patients weighing at least 40 kg. Axatilimab was added to the NCCN guidelines for cGVHD in August 2024. This article summarizes the development milestones leading to this first approval of axatilimab for the treatment of cGVHD.

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Source
http://dx.doi.org/10.1007/s40265-024-02109-1DOI Listing

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