Medicine company Eli Lilly and Company (NYSE: LLY) announced on Monday that it has received U.S. Food and Drug Administration Breakthrough Therapy designation for olomorasib as a monotherapy for adults with previously treated advanced pancreatic cancer carrying a KRAS G12C mutation.
The designation is based on preliminary results from the Phase 1/2 LOXO-RAS-20001 study evaluating olomorasib in patients with KRAS G12C-mutant advanced solid tumours, including pancreatic cancer, and is intended to accelerate the drug's development and regulatory review.
Lilly said there are currently no approved therapies specifically targeting KRAS G12C-mutant pancreatic cancer, a rare form of the disease associated with poor outcomes.
Olomorasib is also being evaluated in multiple clinical studies, including the pivotal SUNRAY-01 and SUNRAY-02 trials in KRAS G12C-mutant non-small cell lung cancer.
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