Revolution Medicines, Inc. announced on July 23, 2025, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to elironrasib, its RAS(ON) G12C-selective inhibitor. This designation is for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
The Breakthrough Therapy Designation is based on data from the Phase 1 RMC-6291-001 clinical trial, which evaluated elironrasib monotherapy in patients with advanced KRAS G12C solid tumors. Results from the trial demonstrated highly competitive antitumor activity, including differentiated safety and tolerability, along with a compelling objective response rate and progression-free survival.
This marks the second Breakthrough Therapy Designation for Revolution Medicines, following daraxonrasib's designation for pancreatic cancer. Elironrasib targets the RAS(ON) form of the RAS G12C variant, which drives approximately 12% of NSCLC cases, addressing a significant unmet medical need as there are currently no fully approved RAS-targeted inhibitors for KRAS G12C NSCLC.
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