Eli Lilly has secured a major regulatory boost for its experimental cancer drug olomorasib, with the US FDA granting Breakthrough Therapy designation for the treatment of previously treated patients with KRAS G12C-mutant advanced pancreatic cancer.

 

The designation could accelerate the development and review of olomorasib, a next-generation targeted therapy designed to block the KRAS G12C protein — a mutation linked to some of the most aggressive and difficult-to-treat cancers.

 

The FDA action applies to adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and whose tumors carry the KRAS G12C mutation, identified through an FDA-approved test.

 

Pancreatic cancer remains one of the deadliest cancers, with around 60,000 new cases diagnosed in the United States each year and approximately 50,000 deaths projected annually. Patients with metastatic disease face particularly poor outcomes, with five-year survival rates below 5%.

 

For people with KRAS G12C-mutant pancreatic cancer, treatment options remain extremely limited. There are currently no approved therapies specifically targeting this mutation in 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’s Breakthrough Therapy designation is based on preliminary results from Lilly’s open-label, multicenter Phase 1/2 LOXO-RAS-20001 study, which is evaluating olomorasib in patients with KRAS G12C-mutant advanced solid tumors, including pancreatic cancer patients who have previously received systemic therapy.

 

Olomorasib, also known as LY3537982, is an investigational oral therapy engineered to selectively target KRAS G12C. Lilly is studying the drug across multiple KRAS G12C-driven cancers, including lung cancer and other advanced solid tumors.

 

KRAS mutations account for approximately 85% of RAS-associated cancers, including around 90% of pancreatic cancers. KRAS G12C mutations are rare in pancreatic cancer, occurring in an estimated 1% to 2% of patients, but researchers say patients with this mutation often face worse outcomes than those without it.

 

The company said the new FDA designation reinforces its focus on developing targeted treatments for cancers driven by specific genetic mutations and addressing areas where patients have significant unmet medical needs.