Eli Lilly said the FDA has granted Breakthrough Therapy designation to olomorasib as a monotherapy for adults with previously treated advanced pancreatic cancer whose tumors carry a KRAS G12C mutation. The designation applies to patients who have received at least one prior systemic therapy and whose mutation is confirmed by an FDA-approved test.
Olomorasib is an investigational next-generation KRAS G12C inhibitor. Lilly said the drug previously received Breakthrough Therapy designation in combination with KEYTRUDA for first-line treatment of patients with KRAS G12C-mutant, PD-L1-high non-small cell lung cancer. With the new pancreatic cancer designation, the company now has two Breakthrough Therapy designations for olomorasib across different KRAS G12C-driven cancers.
Breakthrough Therapy designation is intended to speed development and review of drugs for serious conditions when early clinical evidence suggests the therapy may offer substantial improvement over already approved treatments. Lilly said the decision reflects encouraging preliminary data from the open-label, multicenter Phase 1/2 LOXO-RAS-20001 study in patients with KRAS G12C-mutant advanced solid tumors, including advanced pancreatic cancer.
Pancreatic cancer remains one of the deadliest cancers in the United States, with about 60,000 diagnoses and roughly 50,000 deaths each year. Lilly said outcomes for metastatic disease are typically poor, with five-year survival below 5%, and that there are currently no approved therapies specifically targeting KRAS G12C-mutant pancreatic cancer.
Jacob Van Naarden, who leads Lilly Oncology, said the designation reflects the early potential seen with olomorasib and the urgent need for new treatment options in pancreatic cancer. He added that the drug continues to show broad clinical potential across KRAS G12C-driven tumors.
Lilly said it is studying olomorasib in multiple KRAS G12C-mutant cancer trials.
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