ODAC Applauds Effort, But Votes Against Y-mAbs’ I-Omburtamab In Neuroblastoma

US FDA advisory committee voted unanimously that there was not enough evidence to show the monoclonal antibody improves overall survival, but panelists are hopeful that real-world evidence could eventually get the orphan candidate over the finish line.

Neuroblastoma mountain
ODAC members said more work was needed before I-omburtamab could be approved. • Source: Shutterstock

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