FDA fast-tracks experimental medication for rare pancreatic cancer

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eli Lilly’s experimental medication olomorasib as a potential treatment for previously treated pancreatic cancer in patients whose tumors harbor a specific genetic mutation known as KRAS G12C.

The FDA grants this designation to experimental treatments for serious conditions that show early signs of effectiveness in clinical testing. The designation aims to speed up the development of important new therapies. The FDA had previously granted olomorasib this same designation as a potential treatment for certain forms of lung cancer that carry the KRAS G12C mutation.

“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,” Jacob Van Naarden, executive vice president at Eli Lilly and president of Lilly Oncology, said in a company press release.

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Olomorasib designed to block activity of mutated protein

The gene KRAS provides instructions to make a protein, also called KRAS, that plays key roles in regulating when and how cells grow. In pancreatic tumors and many other types of cancer, this gene often becomes mutated, disrupting the activity of the encoded protein and ultimately driving the uncontrolled cell growth that defines all cancers.

KRAS G12C is a specific type of cancer-driving KRAS mutation; it is present in about 1% to 2% of pancreatic cancers. Olomorasib is an oral therapy specifically designed to block the activity of the mutated KRAS protein in cancers that carry this mutation.

“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,” Van Naarden said.

The new FDA breakthrough designation covers the use of olomorasib in people with pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. The FDA decided to grant the designation based largely on data from a Phase 1/2 study (NCT04956640) that tested olomorasib in people with various types of solid tumors.

Results showed that all evaluable patients with pancreatic cancer experienced a decrease in tumor volume following treatment. The most commonly reported side effects across all patients were diarrhea, nausea, and fatigue.

Eli Lilly is currently running two Phase 3 trials testing olomorasib in people with certain forms of lung cancer.