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03-06-2021 | FDA | News


Sotorasib approved for KRAS-mutated NSCLC in USA

Author: Shreeya Nanda


medwireNews: Following accelerated approval by the US FDA, adult patients with advanced non-small-cell lung cancer (NSCLC) and KRAS G12C mutations can now be treated with sotorasib.

The RAS GTPase family inhibitor is indicated for people with locally advanced or metastatic disease that has progressed after at least one previous line of systemic therapy.

The presence of KRAS G12C mutations needs to be determined by an FDA-approved test, and the agency has also approved the QIAGEN therascreen® KRAS RGQ PCR kit (QIAGEN, Venlo, Netherlands) and the Guardant360® CDx assay (Guardant Health Inc, Redwood City, California, USA) as companion diagnostics for use in tissue and plasma samples, respectively.

“If no mutation is detected in a plasma specimen, the tumor tissue should be tested,” says the FDA.

Sotorasib achieved an objective response rate of 36% and a median response duration of 10 months in the single-arm CodeBreaK 100 trial, which forms the basis of this accelerated approval. The FDA cautions, however, that “[c]ontinued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).”

The recommended dose of sotorasib is 960 mg/day orally with or without food.

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