Editorial: Did Rick Pazdur's big 'no' on Lilly's China-born PD-1 also spell the end for price disruption?
Eli Lilly has a big decision coming Thursday as an FDA advisory committee considers the merits of PD-1 blocker sintilimab, a drug developed in China with partner Innovent. That adcomm could swing either way — but if FDA oncology head Rick Pazdur’s word reigns supreme, sintilimab is already dead in the water.
Pazdur and FDA insiders think they have a compelling case against sintilimab for one reason: The drug’s pivotal trial was conducted in China alone with results that might not translate into a more heterogenous US patient pool.
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