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# Y-mAbs Therapeutics Re-filing BLA for Omburtamab
- URL: https://www.fdaweb.com/y-mabs-therapeutics-re-filing-bla-for-omburtamab/
- Published: 2022-02-11T12:00:00.000Z
- Updated: 2026-09-14T17:32:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151145

Y-mAbs Therapeutics is planning to re-submit a BLA on omburtamab for treating 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 control module and the clinical module.

The company says 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.