Y-mAbs Therapeutics Re-files Omburtamab BLA

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.