FDA preBLA meeting completed with FDA for omburtamab in neuroblastoma.-Y-mAbs Therapeutics
Y-mAbs Therapeutics announced that it recently completed a Pre-Biologics License Application meeting with the FDA regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma.
The Company expects to resubmit the BLA for omburtamab by the end of the first quarter 2022.
A data readout from a single-center clinical study (Study 03-133) of omburtamab conducted at Memorial Sloan Kettering, where 107 evaluable patients with CNS/leptomeningeal metastases from neuroblastoma received up to two doses of radiolabeled omburtamab, showed that patients had a median survival of 50.0 months, with the final median not yet being reached. The Company intends to submit the complete clinical data package in the BLA and announce the data later this year.
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