On October 26, 2022, briefing documents posted to the U.S. Food and Drug Administration (FDA) website identified concerns by FDA scientists regarding data submitted by Y-mAbs Therapeutics, Inc. in support of the company’s Biologics License Application (BLA) for its neuroblastoma therapy, omburtamab.
Key issues identified by the FDA include differences between study and control populations and their impact on the control population as a comparator, results from FDA conducted analyses to examine bias, and a lack of reliable response rate data for supportive evidence of the treatment effect of omburtamab.
Previously, on April 1, 2022, Y-mAbs Therapeutics resubmitted its BLA for omburtamab after the FDA issued a Refuse to File letter regarding the company’s marketing application for the drug in children with CNS/leptomeningeal metastasis from neuroblastoma, citing portions of two modules in the application requiring further detail.
Shares of Y-mAbs Therapeutics, Inc. stock dropped more than 20% in intraday trading on October 26, 2022.
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