BioLineRx Announces Successful Completion of Pre-NDA Meeting with FDA for Motixafortide for Stem Cell Mobilization in Multiple Myeloma Patients
The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA and, in particular, to confirm that the Company's single Phase 3 pivotal study, GENESIS, is sufficient to support an NDA submission. During the pre-NDA meeting, the FDA agreed that the proposed data package is sufficient to support an NDA submission, which the Company continues to anticipate will occur in H1 2022.
"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," stated
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, has reported positive results from a pre-planned pharmacoeconomic study, has successfully completed a pre-NDA meeting with the FDA, and is currently in preparations for an NDA submission. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (
For additional information on
Various statements in this release concerning
View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-successful-completion-of-pre-nda-meeting-with-fda-for-motixafortide-for-stem-cell-mobilization-in-multiple-myeloma-patients-301462623.html