Sotorasib’s Confirmatory Data in NSCLC Unreliable, Says FDA Panel
An FDA advisory committee on Thursday said the confirmatory trial data for the KRAS inhibitor sotorasib (Lumakras) in previously treated non-small cell lung cancer (NSCLC) cannot be reliably interpreted in the CodeBreaK 200 study. Most members of the Oncologic Drugs Advisory Committee (ODAC) agreed with FDA staff that multiple sources of systemic bias during the […]