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Home Amgen's KRAS G12C Inhibitor Sotorasib Faces FDA Panel Scrutiny Over Reliability of Phase III Confirmatory Trial Data

Amgen's KRAS G12C Inhibitor Sotorasib Faces FDA Panel Scrutiny Over Reliability of Phase III Confirmatory Trial Data

Oct 06, 2023 08:09 CST Updated 08:09
Amgen

Developer of Treatment Drugs for Serious Diseases

FDA

U.S. Food and Drug Administration

Sotorasib was granted accelerated approval in 2021, and the current discussion focuses on validating the clinical data from CodeBreak 200. The clinical design of CodeBreak 200 is as follows: mPFS for the Sotorasib group vs. the docetaxel group was 5.6 months vs. 4.5 months, and OS was 10.6 months vs. 11.3 months, respectively.