FDA Grants Breakthrough Therapy Status to a Pancreatic Cancer Drug for a Mutation Found in Roughly 1 in 50 Patients

The FDA has granted Breakthrough Therapy designation to olomorasib as a monotherapy for adults with advanced pancreatic cancer who have already received at least one systemic therapy and whose tumors carry a KRAS G12C mutation.

Eli Lilly announced the designation on August 3. Patients must be identified by an FDA-approved test. Olomorasib is an investigational, highly selective next-generation inhibitor of KRAS G12C, and this is its second such designation, following one granted in September 2025 for use with pembrolizumab in first-line KRAS G12C mutant non-small cell lung cancer with PD-L1 expression of 50 percent or higher.