BioLineRx’s Aphexda (motixafortide) + Filgrastim Receives the US FDA’s Approval for Multiple Myeloma
Shots:
- The US FDA has approved motixafortide + filgrastim (G-CSF) to mobilize hematopoietic stem cells (HSC) to the peripheral blood for collection & subsequent autologous transplantation in patients with MM. The product is expected to be available in Sept 2023
- The approval was based on the 2-part P-III study (GENSIS) evaluating motixafortide + filgrastim vs PBO + filgrastim. The first part of the study focused on determining dosage and incl. 12 patients while the second part randomly assigned 122 patients in a ratio (2:1)
- The study met its 1EPs i.e., 67.5% vs 9.5% of patients reached the stem cell collection goal of 6x10^6 CD34+ cells/kg within 2 apheresis sessions as measured by the central laboratory; 92.5% vs 21.4% by local laboratories. The safety was evaluated in 92 patients with Aphexda (1.25mg/kg, SC) + filgrastim and 42 with PBO + filgrastim
Ref: PR Newswire | Image: BioLineRx
Related News:- BioLineRx's Motixafortide (BL-8040) Receives EC's ODD to Treat Pancreatic Cancer in Europe
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
