BioLineRx Ltd. (NASDAQ: BLRX) has announced the completion of a successful pre-NDA (New Drug Application) meeting with the US FDA about Motixafortide as a proprietary stem-cell mobilization component in autologous bone marrow transplant in patients with multiple myeloma. The company is evaluated its lead cancer therapy platform, motixafortide, in a third phase trial of stem cell mobilization for autologous bone marrow transplant.
BioLineRx seeking NDA approval for motixafortide
The meeting’s goal was to get FDA approval for the proposed NDA’s substance, specifically to certify that BioLineRx’s single Phase III pivotal trial, GENESIS, is adequate to support an NDA filing. The FDA confirmed during the meeting that the anticipated data package is acceptable to support the NDA filing, which the Firm expects to happen in the first half of 2022.
CEO Philip Serlin commented, “We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year.”
Serlin explained that the productive meeting builds on the positive momentum established by the convincing results of the GENESIS Phase III study, which shows a highly substantial improvement over the existing standard of treatment, as well as the favorable results of the company’s recent pharmacoeconomic study. Therefore, once approved, Motixafortide could potentially be the standard-of-care mobilization treatment for various multiple myeloma people having undergone autologous stem cell transplantation, particularly in light of new and extra intensive induction treatment regimens that render stem-cell mobilization more challenging than before.
GENESIS study met both primary and secondary endpoints
BioLineRx stated in May 2021 that the topline findings of their GENESIS Phase III study of Motixafortide in stem-cell mobilization for the treatment of autologous bone marrow transplant in multiple myeloma participants were positive. All primary and secondary objectives were reached with a very high statistical significance (p0.0001). Most importantly, after mobilizing the correct quantity of stem cells with only one dosage of Motixafortide and one apheresis session, 90% of patients moved straight to transplantation.
