On May 28, 2021 the United States Food and Drug Administration (FDA) approved Lumakras (sotorasib) for the first line treatment of advanced non-small cell lung cancer (NSCLC) with tumors having the G12C change in KRAS. The FDA based their approval on the results of the clinical trial CODEBREAK 100 which showed that patients receiving Lumakras (sotorasib) had a higher chance of responding well or not having cancer progression while on treatment.

Lumakras (sotorasib) being available marks the first drug approved by the FDA to target KRAS. This landmark approval finally gives patients with the most common mutation in non-small cell lung cancer hope for a targeted therapy that did not exist before.

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