US FDA’s ODAC: The Advisory Committee That Can Only Say ‘No’

It has been more than two years since a sponsor went before the Oncologic Drugs Advisory Committee and won a favorable vote on approval of a new drug application. Can FDA really expect an advisory committee to keep saying ‘no’ all the time?

FDA stop sign.  Sarah Silbiger/Getty Images
• Source: Sarah Silbiger/Getty Images

Y-mAbs Therapeutics Inc. has every right to be disappointed by the unanimous “no” vote cast by a US Food & Drug Administration panel of experts on the approvability of its proposed neuroblastoma therapy I-omburtamab – but the company has no reason to be surprised.

The vote is in keeping with the recent history of FDA’s Oncologic Drugs Advisory Committee: it has become a committee...

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