……………………. catching up on FDA Approvals
The FDA recently approved a new infused therapy, Niktimvo (axatilimab-csfr) from Incyte Corporation and Syndax Pharmaceuticals, indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
Graft-versus-host disease is a leading cause of death from bone marrow transplants, which are used to treat certain blood cancers, solid tumors and immune disorders. It is estimated that approximately a third of those who receive bone marrow transplants experience GVHD.
Niktimvo doesn’t work like its predecessors which include Incyte’s Jakafi and Sanofi’s Rezurock. Niktimvo is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody that targets and blocks a protein involved in the development and survival of certain kinds of white blood cells.
Analysts suggest that Niktimvo will launch with a list price of $21,500 / month.
The company did not announce details for distribution.
CLICK HERE to access prescribing information
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