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The on Friday as a second-line agent for non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations.

Sotorasib becomes the first approved agent targeting any KRAS mutation. In NSCLC, KRAS G12C mutations account for approximately 13% of all mutations.

"KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, in a statement. "Today's approval represents a significant step towards a future where more patients will have a personalized treatment approach."

Approval was based on data from a study of 124 patients with locally advanced or metastatic NSCLC, all of whom had KRAS G12C mutations and had progressed on either platinum-based chemotherapy, an immune checkpoint inhibitor, or both. Treatment with sotorasib yielded an objective response rate of 36%, with a majority of patients responding for at least 6 months.

The recommended dose is 960 mg, though FDA is requiring a postmarketing trial to test a lower dose of the drug, and as part of the accelerated approval pathway, additional trials will be required to confirm clinical benefit

Common adverse events with sotorasib included "diarrhea, musculoskeletal pain, nausea, fatigue, liver damage, and cough," according to FDA, and clinicians should watch for symptoms of interstitial lung disease (ILD) and permanently discontinue the drug if ILD is diagnosed.

FDA also recommended monitoring patients' liver function before and during treatment and recommended dose reductions or stopping treatment altogether if patients develop liver damage. Also, "patients should avoid taking acid-reducing agents, drugs that induce or are substrates for certain enzymes in the liver and drugs that are substrates of the P-glycoprotein" while taking sotorasib, FDA noted.

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