The US Food and Drug Administration (FDA) has approved Aphexda (motixafortide) in combination with filgrastim (granulocyte colony stimulating factor [G-CSF]) to mobilize hematopoietic stem cells for collection and subsequent autologous transplant in patients with multiple myeloma.
The approval was based on data from the phase 3 GENESIS study (ClinicalTrials.gov Identifier: NCT03246529), which was designed to assess the efficacy and safety of motixafortide plus G-CSF for stem cell mobilization in 122 adults with multiple myeloma. Study participants were randomly assigned 2:1 to receive either motixafortide at 1.25 mg/kg (n=80) or placebo (n=42), each in combination with G-CSF.
The primary endpoint was the collection of at least 6.0 x 106 CD34+ cells/kg in up to 2 apheresis sessions. The endpoint was met by 67.5% of patients in the motixafortide arm and 9.5% of those in the placebo arm (adjusted difference of 56.8%; P <.0001).
Continue Reading
Additionally, a greater proportion of patients treated with motixafortide achieved a cell collection goal of at least 6.0 x 106 CD34+ cells/kg in 1 apheresis session (63.8% vs 2.4% for placebo; P <.0001) and a cell collection goal of at least 2.0 x 106 CD34+ cells/kg in 1 apheresis session (87.5% vs 38.1% for placebo; P <.0001).
Time to neutrophil and platelet engraftment were similar between the arms, as was graft durability after transplant.
Serious adverse events were reported in 5.4% of patients in the motixafortide arm. These included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia, and hypoxia.
Aphexda is supplied in a single-dose vial containing 62 mg of motixafortide as a lyophilized powder for subcutaneous injection after reconstitution. The product is expected to be available later this month.
References
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. News release. BioLineRx Ltd. September 11, 2023. https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-aphexda/
Aphexda™. Package insert. BioLineRx; 2023. Accessed September 11, 2023. https://www.aphexda.com/files/APHEXDA-Prescribing-Information.pdf.
This article originally appeared on MPR
