Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that KRAS p.G12C status confers therapeutic sensitivity to Sotorasib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted accelerated approval to sotorasib for the treatment of 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 product label states that this indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
This statement is based on a regulatory approval from the Food and Drug Administration:
LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of 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. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).