Signal FDA grants breakthrough therapy designation to Lilly's olomorasib for pancreatic cancer

Summary

The US FDA granted Breakthrough Therapy designation to Eli Lilly's olomorasib. The designation covers monotherapy use in adults with KRAS G12C-mutant advanced pancreatic cancer who have already received at least one prior systemic treatment. No approved therapy currently targets KRAS G12C-mutant pancreatic cancer specifically, marking it as an unmet medical need. The designation is expected to speed up the drug's development and regulatory review timeline. That means patients with this mutation could see a new treatment option reach them sooner.