The U.S. FDA has granted Breakthrough Therapy designation to Eli Lilly's olomarasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer.
Olomarasib is an investigational, potent, highly-selective next-generation KRAS G12C inhibitor. The drug treats adults with advanced pancreatic cancer who have previously received systemic therapy. Patients must have a KRAS G12C mutation confirmed by an FDA-approved test.
This latest Breakthrough Therapy designation was granted due to promising preliminary results from the phase 1/2 LOXO-RAS-20001 study of patients with advanced solid tumors. The drug was previously granted Breakthrough Therapy designation in combination with Keytruda (pembrolizumab) as an anti-PD-1 therapy used as a first-line treatment for advanced or metastatic non-small cell lung cancer with KRAS G12C mutation and PD-L1 expression of at least 50%.