Eli Lilly and Company (NYSE:LLY) has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its investigational drug olomorasib as a standalone treatment for adults with advanced pancreatic cancer carrying a KRAS G12C mutation who have previously received at least one systemic therapy.
The designation is intended to accelerate the development and regulatory review of promising therapies for serious diseases where early clinical evidence suggests meaningful improvements over existing treatment options.
Decision Based on Early Clinical Trial Results
The FDA’s decision is supported by preliminary findings from the Phase 1/2 LOXO-RAS-20001 study (NCT04956640).
The open-label, multicenter trial is evaluating olomorasib in patients with advanced solid tumors driven by KRAS G12C mutations, including individuals with previously treated advanced pancreatic cancer.
Second Breakthrough Therapy Designation for Olomorasib
This is the second time olomorasib has received Breakthrough Therapy designation from the FDA.
In September 2025, the agency granted the same status for olomorasib in combination with pembrolizumab as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer harboring a KRAS G12C mutation and PD-L1 expression of at least 50%.
Significant Unmet Need in Pancreatic Cancer
Approximately 60,000 people are diagnosed with pancreatic cancer in the United States each year, and the disease is responsible for an estimated 50,000 deaths annually.
Patients with metastatic pancreatic cancer face a five-year survival rate of less than 5%.
KRAS G12C mutations are found in roughly 1% to 2% of pancreatic cancer cases, and there are currently no approved therapies specifically targeting this mutation in the disease.
Lilly Continues Broader Development Program
Olomorasib (LY3537982) is an investigational oral inhibitor designed to target the KRAS G12C protein.
Commenting on the FDA decision, 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.”
Beyond pancreatic cancer, Lilly is continuing to evaluate olomorasib in the global SUNRAY-01 (NCT06119581) and SUNRAY-02 (NCT06890598) clinical trials for patients with KRAS G12C-mutant non-small cell lung cancer.
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