1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the biologics license application for the investigational medicine I 131 omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma.
The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the biologics license application in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October.