BioLineRx Received US FDA Approval for NDA for APHEXDA® (motixafortidenew ) in Stem Cell Mobilisation
BioLineRx Ltd, a pre-commercial-stage biopharmaceutical company has announced that the U.S. FDA has accepted for review and filed the Company’s New Drug Application (NDA) for APHEXDA® (motixafortide) in stem cell mobilization for autologous transplantation in multiple myeloma patients.
Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for several blood cancers, including multiple myeloma. In the U.S., nearly 15,000 ASCTs are performed each year with the majority in patients with multiple myeloma. With the trend toward more aggressive induction treatment protocols, there is a clear need amongst patients with multiple myeloma to be able to reliably and rapidly secure the necessary amount of stem cells to continue their treatment programs.
Philip Serlin, Chief Executive Officer of BioLineRx stated that APHEXDA has the potential to significantly improve outcomes and treatment experiences for patients with multiple myeloma, and the acceptance of its NDA brings their company closer to this important goal.
The NDA is supported by the results from the GENESIS Phase 3 trial of motixafortide on top of G-CSF (versus placebo on top of G-CSF) in stem cell mobilization for autologous transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). The combination was also found to be safe and well tolerated.
BioLineRx Ltd. is a pre-commercial-stage biopharmaceutical company focused on oncology and its lead development program, motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor, may support diverse therapeutic approaches in oncology and other diseases.