FDA committee members said the trial population of mostly Asian men did not represent the diversity of U.S. patients.
The Fed Is Likely to Still Take a Measured Approach to Rate Hikes Despite Calls for Bigger Action
Dr. Lana Shiu, head of regulatory affairs at Innovent, said sintilimab was well tolerated and showed a significant benefit for patients against multiple tumor types. Dr. David Ferry, head oncological medical strategy at Eli Lilly, said race and body weight has no meaningful impact on the effectiveness of sintilimab.
The companies also did not consult with the FDA through the entire clinical trial. The study began in August 2018 but the FDA was not informed until April 2020, when the companies submitted their results and said they planned to apply for approval.
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