Non-small cell lung cancer (NSCLC) accounts for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide, including approximately 236,000 new cases in the U.S.
Roughly 50% of patients with the most common type of NSCLC, have at least one recognized driver mutation that is causing the cancer and maintains its growth and that is actionable, meaning it has an FDA approved therapy. For approximately 1 in 8 of these U.S. patients, this mutation is KRAS G12C.
A crucial first step is detecting it. This can be done with biomarker testing when advanced NSCLC is first diagnosed. This testing can reveal a patient’s biomarker status and help guide personalized treatment options and potentially improve outcomes. One recent study showed that patients who were tested and received biomarker-directed targeted therapy lived longer and had decreased risk of mortality, versus those who were tested but had no driver mutation identified or did not receive targeted therapy.
“KRAS has challenged cancer researchers for more than 40 years with many deeming it as 'undruggable’,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Patients with advanced non-small cell lung cancer who have failed first-line treatment face extremely poor outcomes with limited treatment options available to them.”
But now, for those people living with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy, there is a new targeted treatment for the first time.
Amgen's LUMAKRASTM (sotorasib), given as a once-daily oral treatment, is the first lung cancer treatment approved by the FDA that specifically targets the mutated protein (KRASG12C) to potentially stop the rapid growth of cancer cells and shrink tumors.
LUMAKRAS™ is 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).