Elironrasib Receives FDA Breakthrough Therapy Designation for Pretreated KRAS G12C+ NSCLC
The FDA has granted breakthrough therapy designation to elironrasib for KRAS G12C–mutated advanced NSCLC previously treated with chemotherapy and immunotherapy.
Elironrasib (RMC‑6291) has been granted FDA breakthrough therapy designation for patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have been previously treated with chemotherapy and immunotherapy and are naïve to a KRAS G12C inhibitor. The designation was based on data from the phase 1 RMC‑6921‑001 trial (NCT 05462717) evaluating elironrasib as monotherapy in patients with KRAS G12C‑mutated advanced solid tumours. In the overall NSCLC population, median time to response was 1.3 months (range 1.1‑4.1) and median time on treatment 3.5 months (range 0.3‑9.8). No grade 4 or 5 adverse events were observed; the most common any‑grade treatment‑related adverse events were diarrhea (29 %), nausea (27 %), prolonged ECG QT interval (25 %), fatigue (13 %), vomiting (13 %) and increased aspartate aminotransferase (11 %).
Elironrasib offers a new therapeutic option for patients with KRAS‑mutant NSCLC who have exhausted standard chemotherapy and immunotherapy, addressing an unmet need for targeted RAS‑pathway inhibition in this population.
Bizonyítékszint: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
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