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

 
• By Derrick Gingery

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

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