Revolution Medicines announces FDA breakthrough therapy designation for zoldonrasib

Revolution Medicines

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.

Read Revolution Medicines press release

Michael Wonder

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Michael Wonder