The US Food and Drug Administration is signaling concerns about relying on Phase III data generated in a single country ahead of a 10 February advisory committee review of Innovent Biologics, Inc./Eli Lilly and Company’s PD-1 inhibitor sintilimab in non-small cell lung cancer.
In a comment published in Lancet Oncology on 4 February, Oncology Center of Excellence leaders Harpreet Singh and Richard Pazdur say the sintilimab application raises questions regarding use of data from a single country – in this
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