Y-mAbs’ External Control Problems May Sink Neuroblastoma Candidate I-Omburtamab

In advisory committee briefing documents, the US FDA said control data was not comparable to the single-arm trial and the benefits of the monoclonal antibody were unclear.

Neuroblastoma cells — The FDA has not approved a therapy for neuroblastoma with CNS/LM relapse. • Source: Shutterstock

Questions about the comparability of Y-mAbs Therapeutics Inc.’s external control data in its I-omburtamab clinical trial suggest US Food and Drug Administration approval may be difficult to achieve.

I-omburtamab, a radiolabeled murine monoclonal antibody, is proposed as a treatment for central nervous system/leptomeningeal (CNS/LM) metastases in pediatric patients...