Posted by Michael Wonder on 02 Apr 2020
Y-mAbs announces submission of naxitamab biologics license application to U.S. FDA
1 April 2020 - Y-mAbs Therapeutics today announced that the Company has completed the submission of its biologics license application under the FDA’s rolling review process for naxitamab after market close on 31 March 2020.
Naxitamab is an investigational, monoclonal antibody that targets GD2. The naxitamab application is for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 201 and 12-230, which the Company expects to present at a venue later this year.
