Based on the results of the single-arm, multicenter, phase I/II CodeBreaK 100 study (NCT03600883), sotorasib received accelerated approval from the US FDA in May 2021 for “adult patients with KRAS G12C‐mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA‐approved test, who have received at least one prior systemic therapy”. The gene discussed is KRAS; the disease is non-small cell lung carcinoma.