Eli Lilly and Company announced its experimental drug, olomorasib, received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). The designation is for the treatment of adult patients with advanced pancreatic cancer harboring a KRAS G12C mutation who have undergone at least one prior systemic therapy. There are currently no approved therapies that specifically target this mutation in pancreatic cancer, representing a significant unmet medical need.
This status is intended to accelerate the development and review of drugs for serious conditions where early clinical evidence suggests a substantial improvement over available treatments. The decision was based on encouraging preliminary results from the Phase 1/2 LOXO-RAS-20001 clinical trial. This is the second such designation for olomorasib, which was previously granted Breakthrough Therapy status for a type of non-small cell lung cancer in 2025.