FDA Accepts NDA for Motixafortide

The U.S. Food and Drug Administration (FDA) has accepted for review and filed the New Drug Application (NDA) for motixafortide, a novel selective inhibitor of the CXCR4 chemokine receptor. Motixafortide is being developed as a platform for the mobilization of hematopoietic stem cells (HSC) in autologous transplantation in patients with multiple myeloma (MM).

The NDA is supported by the results from the phase III GENESIS trial of motixafortide plus granulocyte colony-stimulating factor (G-CSF) versus placebo plus G-CSF in HSC mobilization for autologous transplantation in patients with MM. The study met all primary and secondary endpoints with a high degree of statistical significance (P<.0001). The combination was also found to be safe and well tolerated, according to the manufacturer of the platform.

The FDA has assigned the NDA a Prescription Drug User Fee Act target action date of September 9, 2023.

Source: PR Newswire, November 2022