FDA approves motixafortide plus filgrastim for hematopoietic stem cell mobilization

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.

GENESIS - latest data¹

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.

• Patients who reached the stem cell collection goal of ≥6 × 10⁶ CD34+ cells/kg within two apheresis sessions:
  • motixafortide plus filgrastim cohort, 67.5%
  • placebo plus filgrastim cohort, 9.5%
• Incidence of serious adverse events:
  • motixafortide plus filgrastim cohort, 5.4%
• The most common adverse events were injection site reactions, pruritus, flushing, and back pain.