Motixafortide

(Aphexda®)

Aphexda®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 62 mg)
Drug ClassHematopoietic stem cell mobilizers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for use in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • In adult patients with Multiple Myeloma (MM) undergoing Autologous Hematopoietic Stem Cell Transplantation (ASCT), 92.5% of those treated with motixafortide + G-Cerebrospinal Fluid (CSF) collected ≥6 x 10^6 CD34(+) cells kg(-1) within two apheresis procedures, compared to 26.2% in the placebo + G-CSF group (overall response (OR) 53.3, 95% confidence interval (CI) 14.12-201.33, P < 0.0001). 3. 88.8% of patients in the motixafortide + G-CSF group achieved the target CD34(+) cell collection in one apheresis procedure, compared to 9.5% in the placebo + G-CSF group (OR 118.0, 95% CI 25.36-549.35, P < 0.0001).
  • The most common treatment-emergent adverse events in adult patients with Multiple Myeloma (MM) undergoing ASCT were injection site reactions, including pain (50%), erythema (27.5%), and pruritus (21.3%), all of which were transient and graded as 1/2 in severity.
  • No significant safety concerns or adverse effects were reported beyond mild injection site reactions.
  • The study included adult patients with MM undergoing ASCT, with no significant differences in effectiveness or safety among different subgroups reported.

Product Monograph / Prescribing Information

Document TitleYearSource
Aphexda (motixafortide) Prescribing Information.2023BioLineRx Ltd., Modi’in, Israel

Randomized Controlled Trials