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Motixafortide

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Medication

Pharmaceutical compound
Motixafortide
Clinical data
Trade namesAphexda
Other namesBL-8040
AHFS/Drugs.comMonograph
License data
Routes of
administration		Subcutaneous
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
Chemical and physical data
FormulaC97H144FN33O19S2
Molar mass2159.55 g·mol

Motixafortide, sold under the brand name Aphexda, is a medication used for the treatment of multiple myeloma. Motixafortide is a hematopoietic stem cell mobilizer and a CXCR4 antagonist. It is given by subcutaneous injection.

The most common side effects include injection site reactions, pruritus, flushing, and back pain.

Motixafortide was approved for medical use in the United States in September 2023.

Medical uses

Motixafortide is indicated, in combination with filgrastim, a granulocyte-colony stimulating factor (G-CSF), to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in people with multiple myeloma.

Adverse effects

Motixafortide can cause injection site reactions, anaphylactic shock, and hypersensitivity reactions. Tumor cell mobilization in people with leukemia, leukocytosis, potential for tumor cell mobilization, and embryo-fetal toxicity can also be caused by motixafortide.

History

The US Food and Drug Administration (FDA) approved motixafortide based on evidence from the GENESIS study, a double-blind, placebo-controlled study, in which 122 participants with multiple myeloma, due to undergo autologous transplantation, were randomized 2:1 to receive motixafortide 1.25 mg/kg with granulocyte-colony stimulating factor (N=80) or placebo with granulocyte-colony stimulating factor (N=42) for mobilization of hematopoietic stem cells for collection and apheresis. This one trial evaluated the benefit and side effects of motixafortide in participants. The trial was conducted at 21 sites in five countries including Italy, Hungary, Germany, Spain, and the United States. There were 78 participants included in the trial from the United States, and 44 participants included from sites outside of the United States. The GENESIS trial was used to assess efficacy and safety.

Society and culture

Names

Motixafortide is the international nonproprietary name.

References

  1. ^ "Aphexda- motixafortide injection, powder, lyophilized, for solution". DailyMed. 4 September 2023. Archived from the original on 14 September 2023. Retrieved 13 September 2023.
  2. "Aphexda- motixafortide acetate injection, powder, lyophilized, for solution". DailyMed. 22 September 2023. Retrieved 6 October 2023.
  3. ^ "Drug Trials Snapshots: Aphexda". U.S. Food and Drug Administration (FDA). 11 March 2024. Retrieved 14 March 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ "Aphexda approval letter" (PDF). 8 September 2023. Archived from the original (PDF) on 14 September 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  5. "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" (Press release). BioLineRx Ltd. 11 September 2023. Retrieved 13 September 2023 – via PR Newswire.
  6. World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.

Further reading

External links

  • "Motixafortide (Code C88309)". NCI Thesaurus.
  • Clinical trial number NCT03246529 for "A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With MM (GENESIS)" at ClinicalTrials.gov
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