Nov. 29, 2019 : Y-mAbs Therapeutics, Inc., announced that it is the submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.
In August 2018, naxitamab, which is an anti-GD2 monoclonal antibody, inward Breakthrough Therapy Designation by the FDA that facilitates frequent interactions with the FDA review team.
The Rolling Review process allows Y-mAbs to submit individual portions of the BLA for review, rather than waiting until all portions are completed and submitted to the FDA for review. Upon potential approval, the Company intends to commercialize naxitamab in the U.S. https://fda.einnews.com/pr_news/503569114/y-mabs-initiates-rolling-submission-of-biologics-license-application-to-u-s-fda-for-naxitamab-for-treatment-of-neuroblastoma
