The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC
Shots:
- The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50%
- Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ± CT vs PBO + SoC in KRAS G12C-mutant NSCLC pts
- Lilly to present integrated data of olomorasib + Keytruda in KRAS G12C-mutant NSCLC from LOXO-RAS-20001 & SUNRAY-01 (Abstract #MA02.06) on Sep 7, 2025 at WCLC’25. A second analysis of olomorasib with chemoimmunotherapy (Abstract #OA08.02) will be presented Sep 8, both using a Jun 6, 2025 cutoff
Ref: Eli Lilly | Image: Eli Lilly| Press Release
Related News:- Eli Lilly Reports Topline P-III (monarchE) Trial Data of Verzenio (Abemaciclib) to Treat Early Breast Cancer
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com