FDA Rejects Y-mAbs Therapeutics BLA

The FDA has declined to approve Y-mAbs Therapeutics’ Biologics License Application (BLA) for its 131I-omburtamab candidate in treating central nervous system/leptomeningeal metastasis for patients with neuroblastoma, a type of cancer that forms in early nerve cells and usually develops in children under five years old.

In a Complete Response Letter to the company to explain why it could not approve the BLA, the agency said the supporting data did not demonstrate whether the drug candidate provides a clear benefit in overall survival.

The FDA recommended that the company meet with the agency to discuss a “well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile,” the company said.

Omburtamab was licensed to Y-mAbs Therapeutics by Memorial Sloan Kettering Cancer Center.