Breaking with past comments, FDA's Richard Pazdur telegraphs rough road ahead for Lilly's China-developed cancer drug
The biopharma industry has recently seen a groundswell of companies attempting to get their cancer drugs approved using data from China, namely Eli Lilly and EQRx. But Richard Pazdur, the FDA’s oncology chief, threw cold water on that notion Friday — despite previous comments indicating regulators would be open to the idea.
In The Lancet last Friday, Pazdur wrote that there would be significant hurdles in approving a drug based on data from a single foreign country. In particular, he noted Lilly and Innovent’s Phase III trial evaluating the anti-PD-1 antibody sintilimab, slated for an ODAC adcomm this week, “raises questions” about how data from such populations may prove too homogeneous.
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