Sotorasib

LUMYKRAS is indicated as monotherapy for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.

LUMAKRAS® (sotorasib) is indicated for: • the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.

This indication is issued market authorization with conditions based on objective response rate (ORR) and duration of response (DOR) (see 14 CLINICAL TRIALS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): In clinical studies, no overall differences in safety or efficacy were observed between geriatric patients (≥ 65 years old) and younger patients.

LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and who have progressed after at least one prior line of systemic therapy.