12 December 2022 - Today, the FDA granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics), a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or metastatic non-small-cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy.

FDA also approved the QIAGEN therascreen KRAS RGQ PCR kit (tissue) and the Agilent Resolution ctDx FIRST Assay (plasma) as companion diagnostics for Krazati. If no mutation is detected in a plasma specimen, the tumour tissue should be tested.

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