Lilly’s Olomorasib Gains FDA Breakthrough Therapy Status
Eli Lilly and Company has secured Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for olomorasib, an investigational medicine being developed for adults with advanced pancreatic cancer carrying a KRAS G12C mutation.
The designation covers patients whose disease has progressed following at least one previous systemic treatment.
Olomorasib, also known as LY3537982, is an oral, targeted inhibitor developed to selectively block the KRAS G12C protein.
The FDA’s Breakthrough Therapy programme is designed to support the faster development of medicines that show encouraging early evidence in serious diseases.
The regulatory decision was supported by early findings from the Phase 1/2 LOXO-RAS-20001 clinical study.
The trial is evaluating olomorasib in patients with advanced solid tumours containing a KRAS G12C mutation, including pancreatic cancer.
Pancreatic cancer remains a major area of unmet medical need. Around 60,000 people in the US are diagnosed with the disease each year, while advanced cases continue to have poor survival outcomes.
There are currently no approved medicines specifically designed to treat KRAS G12C-mutated pancreatic cancer.
The latest decision represents olomorasib’s second FDA Breakthrough Therapy designation.
Its first was granted in 2025 for use with pembrolizumab in certain patients with KRAS G12C-mutated advanced or metastatic non-small cell lung cancer.
Lilly is continuing to investigate olomorasib across several KRAS G12C-driven cancers through ongoing clinical programmes.
