Y-mAbs Faces Delay In Pediatric Neuroblastoma With Refuse-To-File Letter

 
• By Joseph Haas
  
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Omburtamab, for CNS metastases resulting from neuroblastoma, needs more clinical and CMC data for its rolling BLA to be reviewed. The company says timelines for lead candidate naxitamab should not be affected.

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An FDA refuse-to-file letter will delay review of Y-mAbs' omburtamab

With two neuroblastoma therapies under review at the US Food and Drug Administration, Y-mAbs Therapeutics Inc.is nearing some significant inflection points, including a 30 November user fee date for its lead candidate naxitamab. But the biotech hit a snag on 5 October when the FDA issued a refuse-to-file letter for the biologics license application (BLA) for its other neuroblastoma candidate, omburtamab.

Both of the monoclonal antibody candidates were in-licensed by Y-mAbs from Memorial Sloan Kettering Cancer Center in 2015 –...

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