The FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The FDA also approved the Guardant360 CDx (Guardant Health) test as a companion diagnostic for amivantamab, a bispecific antibody directed against EGF and MET receptors.