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

Y-mAbs Therapeutics Inc.’s statistical arguments could not convince the US Food and Drug Administration’s Oncologic Drugs Advisory Committee that its I-omburtamab was effective in neuroblastoma, just like it did not sway the agency reviewers.

But advisory committee members indicated that the ground-breaking work Y-mAbs and the FDA are undertaking using real-world data could eventually...