BL 8040 filed with FDA for stem cell mobilization for autologous bone marrow transplantation for multiple myeloma.
BioLineRx announced that the Company has submitted its New Drug Application (NDA) to the FDA for BL 8040 (motixafortide) in stem cell mobilization (SCM) for autologous bone marrow transplantation for multiple myeloma patients
The NDA submission is based on the overwhelmingly positive top-line results from BioLineRx's GENESIS Phase III trial of motixafortide on top of G-CSF (versus placebo on top of G-CSF) in stem cell mobilization for autologous bone marrow 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.
The FDA's decision on acceptance of BioLineRx's NDA filing is expected in November. Assuming the filing is accepted, the potential PDUFA date would be in Q2 2023 (under a priority review process, if applicable) or Q3 2023 (under a standard review process).
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