Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

Y-mAbs got a complete response letter for 131I-omburtamab in metastasis from neuroblastoma • Source: Shutterstock

With a complete response letter for its 131I-omburtamab, Y-mAbs Therapeutics Inc. seems ready to put the B7-H3-directed radiolabeled murine monoclonal antibody to the side and prioritize its development platform and already-approved neuroblastoma drug.

The company said on 1 December that the US Food and Drug Administration had issued a CRL for omburtamab for...

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