The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Eli Lilly and Company’s olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test.
Olomorasib is an investigational, potent and highly selective next-generation inhibitor of KRAS G12C.
Olomorasib was previously granted breakthrough therapy designation, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests.
Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicate that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.
Pancreatic cancer is diagnosed in approximately 60,000 people in the United States each year, with an estimated 50,000 deaths projected annually. Outcomes for patients with metastatic pancreatic cancer are typically poor, with a five-year survival rate under 5%.
Growing evidence suggests outcomes for patients with KRAS G12C-mutant pancreatic cancer are worse than those without the mutation, underscoring a persistent gap in treatment and an opportunity to address a significant unmet need.3 There currently are no approved therapies that specifically target KRAS G12C-mutant pancreatic cancer.
The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the open-label, multicentre, phase 1/2 study of olomorasib in patients with KRAS G12C-mutant, advanced solid tumours, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.
