FDA awards Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant advanced pancreatic cancer in previously treated patients

The US FDA has conferred Breakthrough Therapy designation upon olomorasib, used as a standalone treatment, for adults carrying a KRAS G12C mutation in advanced pancreatic cancer who have already undergone at least one prior systemic treatment, with the mutation confirmed through an FDA-sanctioned diagnostic test. A powerful and highly selective investigational inhibitor of KRAS G12C developed for the next generation of targeted therapy, olomorasib had earlier earned a separate Breakthrough Therapy designation when paired with the anti-PD-1 agent KEYTRUDA (pembrolizumab) for first-line management of locally advanced or metastatic non-small cell lung cancer in patients whose tumours carry a KRAS G12C mutation and whose PD-L1 expression reaches 50% or above.

Breakthrough Therapy designation exists to hasten the path from development to review for medicines directed at grave conditions, where early clinical signals suggest the potential to outperform fully approved treatment alternatives on endpoints that carry genuine clinical weight.

Each year, close to 60,000 people across the United States learn they have pancreatic cancer, and around 50,000 of those diagnosed are not expected to survive. The prognosis for metastatic pancreatic cancer is bleak, with fewer than one in twenty patients alive five years after diagnosis. A gathering body of research points to even poorer survival for those whose tumours harbour a KRAS G12C mutation compared to patients without it, revealing a stark therapeutic void and an urgent case for targeted intervention. No medicine currently approved takes direct aim at 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.”

Promising early data from the open-label, multicentre Phase 1/2 LOXO-RAS-20001 study of olomorasib in patients with advanced solid tumours carrying KRAS G12C mutations, a cohort that includes those with advanced pancreatic cancer who had received at least one prior systemic regimen, provided the clinical basis for the FDA’s determination.

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