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On September 11, 2023, the U.S. Food and Drug Administration granted approval to motixafortide plus filgrastim for use in mobilization of hematopoietic stem cells for collection and subsequent autologous transplant.1
Motixafortide, a cyclic-peptide CXCR4 inhibitor, in combination with filgrastim, a type of granulocyte colony-stimulating factor, has been approved based on data from the phase III GENESIS trial (NCT03246529). The trial design and interim data from GENESIS have previously been reported by the Multiple Myeloma Hub here.
The latest analysis from GENESIS includes 92 patients treated with 1.25 mg/kg motixafortide plus filgrastim subcutaneously, and 42 patients treated with a placebo plus filgrastim.
Positive topline results from phase III GENESIS trial of motixafortide + G-CSF for hematopoietic stem cell mobilization
On May 4, 2021, positive topline results were announced for the phase III GENESIS trial (NCT03246529) of motixafortide (BL-8040)...
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