FDA grants breakthrough therapy designation to Lilly’s olomorasib

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eli Lilly and Company's olomorasib for treating advanced pancreatic cancer in adults who have received at least one prior systemic therapy. The drug is intended for patients whose tumors demonstrate a KRAS G12C mutation confirmed by an FDA-approved test. Olomorasib is an investigational inhibitor of the KRAS G12C protein belonging to a class of next-generation therapies being studied for various solid tumors. This is the second breakthrough therapy designation the drug has received from the FDA – the first was granted in September 2025 for combination use with Keytruda for first-line treatment of metastatic or locally advanced lung cancer. The FDA's decision was based on preliminary findings from the LOXO-RAS-20001 clinical trial. KRAS mutations occur in 90 percent of pancreatic cancer cases, with the G12C subtype estimated to appear in 1 to 2 percent of patients with this disease.