FDA Grants Breakthrough Therapy Designation to Revolution Medicines' Zoldonrasib for KRAS G12D-Mutated NSCLC
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Revolution Medicines Inc. announced that the FDA has granted Breakthrough Therapy Designation to zoldonrasib, a selective inhibitor for KRAS G12D-mutated non-small cell lung cancer (NSCLC). This designation is for adult patients who have previously undergone anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. Zoldonrasib is the first drug targeting the KRAS G12D mutation in NSCLC, addressing a significant unmet need. The designation aims to expedite the development of new medicines that show substantial improvement over existing treatments.
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