Eli Lilly: olomorasib receives FDA Breakthrough Therapy for previously treated KRAS G12C advanced pancreatic cancer

Regulatory decision

The U.S. FDA granted Breakthrough Therapy designation to olomorasib as a monotherapy for adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and whose tumors harbor a KRAS G12C mutation as determined by an FDA‑approved test. Breakthrough designation is intended to expedite development and review when preliminary clinical evidence indicates a drug may offer substantial improvement over available therapies.

Clinical evidence

The designation is based on encouraging preliminary results from the open‑label, multicenter Phase 1/2 LOXO‑RAS‑20001 study (NCT04956640) of olomorasib in patients with KRAS G12C‑mutant advanced solid tumors, including previously treated pancreatic cancer patients.

Disease context

Pancreatic cancer is diagnosed in about 60,000 people annually in the U.S., with roughly 50,000 projected deaths each year; metastatic disease has a five‑year survival rate under 5%. There are currently no approved therapies that specifically target KRAS G12C‑mutant pancreatic cancer.

Development programme

Olomorasib is described as a potent, highly selective next‑generation KRAS G12C inhibitor and is being studied across multiple KRAS G12C‑mutant cancers. The molecule had previously received Breakthrough Therapy designation for use with pembrolizumab (KEYTRUDA) in first‑line KRAS G12C NSCLC with PD‑L1 ≥50%.