The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) – the first FDA approved treatment for this strain of lung cancer. The approval is based on results from findings in the Phase II CodeBreak 100 study– the largest clinical trial for patients with the KRAS mutation. Based on the clinical trial data, participants receiving Lumakras had a confirmed objective response rate (ORR) of 36% and a disease control rate of 81%. KRAS has been a point of pain for cancer researchers for more than 40 years, calling the FDA approval a “breakthrough moment” for patients around the world.
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