- The FDA granted breakthrough therapy designation to olomorasib as a monotherapy for adults with KRAS G12C-mutant advanced pancreatic cancer who have received at least one prior systemic therapy.
- Olomorasib previously received breakthrough therapy designation in combination with Keytruda for the first-line treatment of certain patients with KRAS G12C-mutant non-small cell lung cancer.
- The designation is based on preliminary results from the Phase 1/2 LOXO-RAS-20001 study evaluating the drug in patients with KRAS G12C-mutant advanced solid tumors.
Quotes
“Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a _KRAS_ G12C mutation face limited options once their disease progresses,”