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

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 – omburtamab is radiolabeled with Iodine-131 and targets B7-H3 and is being developed to treat central nervous system/leptomeningeal metastases from neuroblastoma in pediatric patients