Revolution Medicine’s Elironrasib Receives FDA Breakthrough Therapy Status for KRAS G12C-Mutated Lung Cancer
Revolution Medicines has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its investigational drug, elironrasib.
The designation applies to the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
Eligible patients must have already undergone chemotherapy and immunotherapy but not a KRAS G12C inhibitor.
This decision by the FDA is based on preliminary results from an ongoing Phase 1 clinical trial (RMC-6291-001), which is evaluating elironrasib as a monotherapy in individuals with advanced solid tumors featuring the KRAS G12C mutation.
Early data indicate the treatment has demonstrated promising anti-tumor activity, a favorable safety profile, and encouraging response and progression-free survival outcomes.
Elironrasib is engineered to bind selectively and irreversibly to the active form (RAS(ON)) of the KRAS G12C protein, a mutation seen in about 12% of NSCLC cases. Revolution Medicines is currently assessing the therapy both as a standalone treatment and in combination with other agents, aiming to pursue multiple development strategies.
NSCLC represents approximately 80% to 85% of all lung cancer cases, with many patients diagnosed at an advanced or metastatic stage. Among genetic mutations in NSCLC, KRAS alterations are among the most common, with KRAS G12C being the leading subtype.
Currently, treatment options targeting RAS mutations remain limited, and no fully approved therapies specifically address this mutation in this patient population.
This is the second Breakthrough Therapy designation that the company has received for its RAS-targeted drug development pipeline.
A similar designation was recently granted for daraxonrasib, aimed at treating advanced RAS-mutant pancreatic cancer. Revolution Medicines’ broader strategy focuses on advancing innovative therapies for difficult-to-treat cancers driven by RAS mutations.
The FDA’s Breakthrough Therapy designation is designed to expedite the development and regulatory review of drugs that may significantly improve treatment for serious or life-threatening conditions.
