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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