Y-mabs therapeutics, inc. initiates rolling submission of biologics license application to u.s. fda for naxitamab for treatment of neuroblastoma

Y-mabs therapeutics, inc. announced that it has submitted to the u.s. food and drug administration 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 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. msk has institutional financial interests with y-mabs in the form of equity and intellectual property interests through licensing agreements. dr. cheung is a founder of, holds equity interests in, and has intellectual property rights related to y-mabs.
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