Therapeutic Response

KRAS p.G12C status confers therapeutic sensitivity to Sotorasib in patients with Non-Small Cell Lung Cancer.

Statements

Source and description
Lumakras (sotorasib) [package insert]. FDA. 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).
Lumykras (sotorasib) [product information]. EMA. The European Medicines Agency (EMA) has authorized sotorasib as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS p.G12C variant and who have progressed after at least one prior line of systemic therapy.