FDA slaps CRL on Y-mAbs' omburtamab BLA

Unsurprisingly given a negative advisory committee vote a few weeks ago, the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine 131I-omburtamab in the treatment of CNS/leptomeningeal metastasis from neuroblastoma, submitted by US biotech Y-mAbs Therapeutics (Nasdaq: YMAB).

News of the negative FDA decision sent Y-mAbs’ share tumbling nearly 17% to $3.75 in pre-market trading this morning.

The letter indicates that the FDA completed the review of the application and determined that it is unable to approve the BLA in its current form. This is consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in October, when panelists voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival. The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.