FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy
Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy.
Key Points
• Sotorasib (Lumakras) is an inhibitor of the RAS GTPase family, and the first KRAS-targeted therapy to be approved by the FDA. This agent is indicated for adults with KRAS G12C‑mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed past first-line treatment and are currently left with few treatment options
• FDA approval was rooted in results from the CodeBreak 100 trial, in which 124 locally advanced or metastatic NSCLC patients with KRAS G12C mutations were administered sotorasib 960 mg orally daily until disease progression or severe toxicity..
• In the trial, the objective response rate (ORR), which was 36% (95% CI: 28%, 45%), and the median response duration was 10 months. In other results, 81% of patients attained disease control, which was defined as the number of patients who achieved complete response, partial response, and stable disease lasting 3 or more months.