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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

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 with neuroblastoma following standard multimodality treatment for CNS disease, a...

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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