FDA issues Complete Response Letter for omburtamab in CNS/leptomeningeal metastasis from neuroblastoma.- Y-mAbs Therapeutics
Y-mAbs Therapeutics announced that the FDA has issued a complete response letter for the Biologics License Application for the investigational medicine 131I-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 BLA in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October. The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile. Y-mAbs is assessing the implications of the CRL and its plans for the omburtamab program.
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