The FDA has granted accelerated approval to adagrasib (Krazati, Mirati), a RAS GTPase family inhibitor, for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.
The agency also approved the Qiagen Therascreen KRAS RGQ PCR kit (tissue) and the Agilent Resolution ctDx First assay (plasma) as companion diagnostics for adagrasib. If no mutation is detected in a plasma specimen, the tumor tissue