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Y-mAbs Therapeutics announced today that it has completed the submission of a Biologics License Application (BLA) to the U.
Omburtamab is an investigational monoclonal antibody targeting B7-H3, an immune checkpoint molecule widely expressed in tumor cells of several cancer types
This submission is based on safety and efficacy results from a pivotal Phase 2 clinical trial
Image source: Y-mAbs official website
"We believe this radioimmunotherapy can potentially address the significant unmet need in children with neuroblastoma with CNS/leptomeningeal metastases," said Dr.
References:
[1] Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA.