Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to its investigational drug olomorasib as a monotherapy for adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and carry a KRAS G12C mutation.

The designation is based on preliminary results from the Phase 1/2 LOXO-RAS-20001 study (NCT04956640), an open-label, multicenter trial evaluating olomorasib in patients with KRAS G12C-mutant advanced solid tumors, including those with previously treated advanced pancreatic cancer.

This marks the second Breakthrough Therapy designation for olomorasib. The first was granted in September 2025 for the drug in combination with pembrolizumab for first-line treatment of patients with advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and PD-L1 expression of 50% or greater.

Pancreatic cancer is diagnosed in approximately 60,000 people in the United States each year, with an estimated 50,000 deaths annually. The five-year survival rate for metastatic pancreatic cancer is under 5%. KRAS G12C mutations occur in approximately 1% to 2% of pancreatic cancer patients, and there are currently no approved therapies specifically targeting this mutation in that cancer type.

Olomorasib (LY3537982) is an oral, investigational inhibitor of the KRAS G12C protein. The FDA's Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious conditions when preliminary clinical evidence suggests potential substantial improvement over existing approved therapies.

Jacob Van Naarden, executive vice president and president of Lilly Oncology, said the designation "reflects the early potential we're seeing with olomorasib in this setting and the critical need for new treatment options."

Lilly is also studying olomorasib in the SUNRAY-01 (NCT06119581) and SUNRAY-02 (NCT06890598) global trials in KRAS G12C-mutant non-small cell lung cancer.