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FDA Panel Votes That Phase 3 PFS Data for Sotorasib in KRAS G12C+ Advanced NSCLC Cannot Be Reliably Interpreted

In a 10-to-2 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the data for progression-free survival per blinded independent central review from the phase 3 CodeBreaK 200 trial evaluating sotorasib vs docetaxel for the treatment of patients with pretreated, locally advanced or metastatic KRAS G12C–mutated non–small cell lung cancer cannot be reliably interpreted. ....

Markr Conaway , Jorge Nieva , Ravia Madan , Jeevan Puthiamadathil , Division Of Translational Research , University Of Virginia School Medicine , National Cancer Institute , Keck School Of Medicine , Statistics Department Of Public Health Sciences , University Of Southern California , Oncologic Drugs Advisory Committee , Drugs Advisory Committee , Translational Research , Applied Statistics Department , Public Health Sciences , Virginia School , Keck School , Southern California ,