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Revolution Medicines Announces FDA Breakthrough Therapy Designation for Zoldonrasib
Breakthrough Therapy Designation granted to zoldonrasib for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic non-small
About this update from Revolution Medicines, Inc.
[{"type":"text","content":"Breakthrough Therapy Designation granted to zoldonrasib for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapyFirst Breakthrough Therapy Designation for an investigational drug specifically targeting KRAS G12D mutation in NSCLCRevolution Medicines’ third RAS(ON) inhibitor to receive this designation REDWOOD CITY, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (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 NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. The Breakthrough Therapy Designation is based on data from the monotherapy cohort of the Phase 1 RMC-9805-001 clinical trial evaluating zoldonrasib in patients with advanced KRAS G12D solid tumors. Results from the monotherapy cohort of the trial have demonstrated a robust clinical profile, including encouraging antitumor activity and acceptable safety and tolerability. “The Breakthrough Therapy Designation for zoldonrasib, our RAS(ON) G12D-selective covalent inhibitor – the first ever granted for an investigational drug specifically targeting the RAS G12D mutation – underscores the significant unmet need for patients with KRAS G12D cancers, which currently lack any approved targeted therapies,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “This recognition expands upon prior designations for the RAS(ON) multi-selective inhibitor daraxonrasib and G12C-selective inhibitor elironrasib, further recognizing the promise of our first three clinical-stage RAS(ON) inhibitors as potentially transformative therapies for people living with RAS-addicted cancers.” Zoldonrasib is an innovative tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. Revolution Medicines is evaluating zold...