FDA granted breakthrough therapy designation to Lilly’s next-generation KRAS G12C inhibitor olomorasib for advanced pancreatic cancer with KRAS G12C mutations after at least one prior systemic therapy. The designation covers patients selected by an FDA-approved test, and is based on preliminary phase 1/2 LOXO-RAS-20001 trial (NCT04956640) data in KRAS G12C-mutant advanced solid tumors, including pancreatic cancer. Lilly highlighted that olomorasib already has a separate breakthrough therapy designation in combination with pembrolizumab for first-line KRAS G12C–mutant NSCLC, underscoring an expanding regulatory pathway for the same drug class across tumor types. While breakthrough status shortens review timelines when a complete application is submitted, the therapy remains investigational for pancreatic cancer pending further trial evidence.