Posted by Michael Wonder on 01 Jul 2020
Y-mAbs announces initiation of submission of omburtamab rolling biologics license application to the FDA
30 June 2020 - Y-mAbs Therapeutics today announced that the Company has initiated the submission of its biologics license application for omburtamab under the U.S. FDA rolling review process.
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 BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.
The non-clinical portion and a part of the CMC portion of the rolling BLA were submitted during June 2020, and completion of the BLA submission is currently expected to take place over the next four to six weeks. The clinical submission will be based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present later this year.
