Posted by Michael Wonder on 07 Aug 2020
Y-mAbs announces completion of submission of omburtamab biologics license application to FDA
6 August 2020 - Y-mAbs Therapeutics today announced that on 5 August 2020, the Company completed the submission of its biologics license application under the FDA’s rolling review process for omburtamab.
Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumour cells of several cancer types. The omburtamab application is for the treatment of paediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.
The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year.
