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FDA grants Breakthrough Therapy status to olomorasib for advanced pancreatic cancer with KRAS G12C mutation

Market News
03 Aug 2026
PRNewsWire
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Bullish
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Eli Lilly's investigational drug olomorasib received FDA Breakthrough Therapy designation for treating advanced pancreatic cancer patients with the KRAS G12C mutation who have had prior systemic therapy. This designation aims to speed up development and review due to promising early results from a Phase 1/2 trial showing potential benefits in this hard-to-treat cancer with limited options. Olomorasib is a selective KRAS G12C inhibitor also being studied for lung cancer, highlighting its broad potential in targeting KRAS G12C-driven tumors. The drug now has two Breakthrough Therapy designations, reflecting its promise in addressing significant unmet medical needs.

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