Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to 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.1 Outcomes for patients with metastatic pancreatic cancer are typically poor, with a five-year survival rate under 5%.2 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.
“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,” said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. “This Breakthrough Therapy designation reflects the early potential we’re seeing with olomorasib in this setting and the critical need for new treatment options. With now two Breakthrough Therapy designations across pancreatic and lung cancers, olomorasib continues to demonstrate broad potential clinical evidence across KRAS G12C-driven tumors and reflects our commitment to bringing meaningful new treatment options to patients living with these cancers.”
The FDA Breakthrough Therapy designation is based on encouraging preliminary results from the open-label, multicenter, Phase 1/2 LOXO-RAS-20001 study (NCT04956640) of olomorasib in patients with KRAS G12C-mutant, advanced solid tumors, including those with advanced pancreatic cancer who have received at least one prior systemic therapy.