Aphexda FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 12, 2023.
FDA Approved: Yes (First approved September 8, 2023)
Brand name: Aphexda
Generic name: motixafortide
Dosage form: Lyophilized Powder for Injection
Company: BioLineRx Ltd.
Treatment for: Hematopoietic Stem Cell Mobilization
Aphexda (motixafortide) is a hematopoietic stem cell mobilizer indicated 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.
- Autologous stem cell transplantation is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In autologous stem cell transplantation, the patient's own stem cells are collected from their blood or bone marrow prior to receiving high-dose chemotherapy, then infused back into the patient, where they travel back to the bone marrow to begin producing new blood cells.
- Aphexda contains motixafortide which is a C-X-C Motif Chemokine Receptor 4 (CXCR4) antagonist that works by blocking the binding of its cognate ligand, stromal-derived factor-1α (SDF-1α)/C-X-C Motif Chemokine Ligand 12 (CXCL12) to mobilize hematopoietic stem cells into the peripheral blood for collection and transplant.
- FDA approval of Aphexda was based on results from the two-part Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Aphexda (motixafortide) plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Aphexda plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg within two apheresis sessions, versus 9.5% for the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the Aphexda arm and 21.4% in the placebo arm.
- Aphexda is administered by subcutaneous injection after filgrastim has been administered daily for 4 days.
- Warnings and precautions associated with Aphexda include anaphylactic shock and hypersensitivity reactions (premedicate with an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor), injection site reactions (premedicate with an analgesic), mobilization of leukemic cells in patients with leukemia, leukocytosis, potential for tumor cell mobilization, and embryo-fetal toxicity.
- Common adverse reactions include injection site reactions, injection site pain, injection site erythema, injection site pruritus, pruritus, flushing, and back pain.
Development timeline for Aphexda
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
