Posted by Michael Wonder on 30 Nov 2019
Y-mAbs initiates rolling submission of biologics license application to U.S. FDA for naxitamab for treatment of neuroblastoma
29 November 2019 - Y-mAbs Therapeutics today announced that it has submitted to the U.S. FDA the first portions of its biologics license application 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, received breakthrough therapy designation by the FDA, which facilitates frequent interactions with the FDA review team.
The rolling review process allows Y-mAbs to submit individual portions of the application for review, rather than waiting until all portions are completed and submitted to the FDA for review. Upon potential approval, the Company intends to commercialise naxitamab in the U.S.
