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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
This independent educational activity is supported by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech. All content is developed independently by the faculty. The funder is allowed no influence on the content of this activity.
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FDA approves motixafortide plus filgrastim for hematopoietic stem cell mobilization
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.
- 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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