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Sotorasib Receives Approval for NSCLC With KRAS G12C Mutations

By: JNCCN 360 Staff
Posted: Tuesday, June 1, 2021

On May 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval for the targeted therapy sotorasib (Lumakras) for the first treatment of adult patients with non–small cell lung cancer (NSCLC) with tumors containing the KRAS G12C mutation and who had at least one prior systemic therapy. Sotorasib marks the first targeted therapy for tumors with any KRAS mutation. A simultaneous approval was given to the therascreen KRAS RGQ PCR Kit to be used as a companion diagnostic for sotorasib.

The FDA approval was based on a study evaluating the efficacy of sotorasib in 124 patients with locally advanced or metastatic KRAS G12C–mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy. Results showed an objective response rate of 36%, and 58% of those patients had a duration of response of 6 months or longer.

Sotorasib is approved for a 960-mg dose. The most common side effects observed in patients taking sotorasib included diarrhea, musculoskeletal pain, nausea, fatigue, liver damage, and cough. As part of the evaluation for the accelerated approval, the FDA requires an additional trial to investigate the efficacy and clinical benefit of a lower dose.



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