8 January 2026 - First breakthrough therapy designation for an investigational drug specifically targeting KRAS G12D mutation in non-small cell lung cancer.
Revolution Medicines today announced that the US FDA has granted breakthrough therapy designation to zoldonrasib, a RAS(ON) G12D selective inhibitor, for the treatment of adult patients with KRAS G12D mutated locally advanced or metastatic non-small cell lung cancer who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.