Eli Lilly received FDA Breakthrough Therapy designation for its drug olomorasib.
The treatment targets adult patients with KRAS G12C-mutant advanced pancreatic cancer. Eligible patients must have previously received at least one systemic therapy.
The FDA based its decision on preliminary data from the ongoing Phase 1/2 LOXO-RAS-20001 clinical trial.
Breakthrough status fast-tracks the development and review of drugs for serious conditions. The designation requires clinical evidence indicating substantial improvement over available therapies.