Blog Post

FDA’s Loud and Clear Message: Engage with FDA Early and Formally

MoFo Life Sciences

09 Mar 2022

On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in China. Rather than following the traditional paradigm of assessing the risk-benefit profile of a single drug, the committee was, in a significant departure from typical Advisory Committee practice, asked to vote on a single question: Whether additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision. The committee ultimately voted 14–1 in support of the need for additional clinical trials, potentially delaying sintilimab’s approval in the United States by years. Yet, with more than 25 drug applications from China pending before the FDA, according to Dr. Richard Pazdur in his February 4, 2022 article in The Lancet, the more pressing question is whether the panel’s decision has any relevance beyond sintilimab. While there is no quick answer, the loud and clear message is that sponsors need to engage with the FDA early and formally if they seek FDA approval for their drugs.

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