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# Y-mAbs Therapeutics Re-files Omburtamab BLA
- URL: https://www.fdaweb.com/y-mabs-therapeutics-re-files-omburtamab-bla/
- Published: 2022-04-01T12:00:00.000Z
- Updated: 2026-09-14T17:39:04.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151505

Y-mAbs Therapeutics has re-submitted a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma after what it characterizes as a positive pre-BLA meeting with FDA reviewers. In 10/2020, FDA issued a refuse-to-file letter on the therapy due to deficiencies with the submission’s chemistry, manufacturing and controls module and the clinical module.  

The company said the resubmission will include a data readout from a single-center clinical study (Study 03-133) of omburtamab conducted at Memorial Sloan Kettering, where 107 evaluable patients with CNS/leptomeningeal metastases from neuroblastoma received up to two doses of radiolabeled omburtamab. Data showed that patients had a median survival of 50 months, with the final median not yet being reached.  

Y-mAbs describes omburtamab as an investigational monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.