The U.S. Food and Drug Administration has granted breakthrough therapy designation to Eli Lilly’s olomorasib for a hard-to-treat form of pancreatic cancer — a step meant to speed the development of promising therapies.
Announced August 4, 2026, the designation covers olomorasib as a single-agent treatment for adults with advanced pancreatic cancer carrying a KRAS G12C mutation who have already had at least one prior systemic therapy. Olomorasib (also known as LY3537982) is a next-generation inhibitor of KRAS G12C, a mutated form of a protein that helps drive tumor growth.
Why pancreatic cancer is so hard
KRAS mutations appear in roughly 90% of pancreatic cancers, but the specific G12C subtype accounts for only about 1–2% of patients. Pancreatic cancer is among the deadliest and most treatment-resistant cancers, so even incremental options matter. “Pancreatic cancer has historically been one of the most difficult-to-treat cancers,” said Lilly executive vice-president Jacob Van Naarden, adding that olomorasib “continues to demonstrate broad potential.”
The evidence and what’s next
The designation rests on early findings from the open-label Phase 1/2 LOXO-RAS-20001 trial, which is testing olomorasib’s safety and efficacy across KRAS G12C-mutant solid tumors, including previously treated pancreatic cancer. Lilly is also pursuing the drug in lung cancer: in September 2025 it received a breakthrough designation for olomorasib combined with Keytruda in first-line, PD-L1-high non-small cell lung cancer. Breakthrough status can shorten development timelines, but the drug still needs confirmatory trials before any approval.