03/08/2026 US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer FDA Grants Orphan Drug Designation to DLL3-Targeting ADC Zoci, for Neuroendocrine Carcinomas US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer (Ref) Eli Lilly announced that the US FDA has granted Breakthrough Therapy designation to olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant a

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation for metastatic KRAS G12C-mutant NSCLC (Ref) The US FDA granted the Breakthrough Therapy designation to Eli Lilly and Company's olomorasib (KRAS G12C inhibitor) + Merck & Co/MSD's pembrolizumab (anti-PD-1), for the first-line treatment of unresectable advanced or metastatic NSCLC with a KRAS G12C mutation and PD-L1 expression ≥ 50%. The designation was b