Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib as a monotherapy for adults with previously treated advanced pancreatic cancer carrying a KRAS G12C mutation, identified through an FDA-approved diagnostic test.
Olomorasib is an investigational, highly selective next-generation KRAS G12C inhibitor being developed to target cancers driven by the KRAS G12C mutation. The FDA’s Breakthrough Therapy designation is designed to accelerate the development and review of investigational therapies that show promising clinical potential for serious diseases with significant unmet medical needs.
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“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 based on preliminary results from the ongoing Phase 1/2 LOXO-RAS-20001 clinical study, which is evaluating olomorasib in patients with KRAS G12C-mutant advanced solid tumors, including pancreatic cancer, who have received at least one prior systemic therapy.
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This is the second FDA Breakthrough Therapy designation for olomorasib. The therapy had previously received the designation in combination with KEYTRUDA® (pembrolizumab) for the first-line treatment of patients with KRAS G12C-mutant advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression, further supporting its potential across multiple KRAS G12C-driven cancers.
