Lilly’s olomorasib granted US FDA Breakthrough Therapy designation for previously treated KRAS G12C-mutant advanced pancreatic cancer

Eli Lilly has recently announced that the US FDA has awarded Breakthrough Therapy designation to olomorasib as a monotherapy for adults with advanced pancreatic cancer carrying a KRAS G12C mutation, as identified by an FDA-approved test, who have already received at least one prior systemic therapy. Olomorasib is an investigational, potent, and highly selective next-generation inhibitor of KRAS G12C. The therapy had previously received Breakthrough Therapy designation in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer carrying a KRAS G12C mutation and PD-L1 expression of 50% or above.

Breakthrough Therapy designation is a mechanism designed to accelerate the development and regulatory review of medicines targeting serious conditions where early clinical evidence points to a potential for substantial improvement over currently approved therapies on clinically meaningful endpoints.

Around 60,000 people in the United States receive a pancreatic cancer diagnosis each year, with approximately 50,000 deaths projected annually. Outcomes for those with metastatic pancreatic cancer are characteristically poor, with a five-year survival rate below 5%. Accumulating evidence indicates that patients whose tumours carry a KRAS G12C mutation face even worse outcomes than those without it, highlighting a persistent treatment gap and a meaningful opportunity to address unmet need. No therapies specifically targeting KRAS G12C-mutant pancreatic cancer are currently approved.

“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 designation is grounded in encouraging preliminary findings from the open-label, multicentre Phase 1/2 LOXO-RAS-20001 study of olomorasib in patients with KRAS G12C-mutant advanced solid tumours, including those with advanced pancreatic cancer who had received at least one prior systemic therapy.

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KRAS G12C-mutant, Lilly's olomorasib, pancreatic cancer