Feb. 26, 2020: Therapeutics announced that it has completed a positive Type B Pre-Biologics License Application (“Pre-BLA”) meeting with the U.S.FDA regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma.
At the pre-BLA meeting, the Company reached placement with the FDA on an Accelerated Approval Pathway for omburtamab along with the rolling BLA submission. The Company expects to complete the rolling BLA in about 10 weeks.
“Under omburtamab’s breakthrough therapy designation, omburtamab qualifies for the rolling BLA submission, which allows for individual modules of the application to be submitted by Company and reviewed by the FDA on a rolling basis, rather than waiting for all sections of the BLA application to be completed before submission.”
“As formerly announced data readout from a single-center study (Study 03-133), at Memorial Sloan Kettering Cancer Center (“MSK”) where the 107 evaluable patients with the CNS/leptomeningeal metastases from neuroblastoma received up to two doses of the radiolabeled omburtamab and showed that the patients had a median survival of 50.8 months, with the final median survival not yet being reached. The Company plans to announce the complete clinical data package later this year. Additionally, the Company is planning for the submission of a Marketing Authorization Application in Europe in the fourth quarter this year.
Researchers at the MSK developed the omburtamab antibody, which is completely licensed by MSK to Y-mAbs. Consequently, MSK has institutional financial interests in the product and in Y-mAbs”.
About Y-mAbs: “Y-mAbs is a late-stage clinical biopharmaceutical company that focus on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline that includes two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, correspondingly.”
https://fda.einnews.com/pr_news/510656396/y-mabs-announces-positive-pre-bla-meeting-with-fda-for-omburtamab
