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2023-09-14T09:01:46.000Z

FDA approves motixafortide plus filgrastim for hematopoietic stem cell mobilization

Sep 14, 2023
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Learning objective: After reading this article, learners will be able to cite a new clinical development in multiple myeloma.

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.            

  1.  BioLineRx Announces FDA Approval of APHEXDA™ (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma. https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-announces-fda-approval-aphexdatm-motixafortide. Published September 11, 2023. Accessed September 13, 2023.

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