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

06 Oct 2020

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.

FDASignBldg21Entrance_1200x675 — 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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ASCO: Pushing The Frontiers Of ADCs

19 Jun 2025

• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.