21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal growth factor and MET receptors, for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.

The FDA also approved the Guardant360 CDx (Guardant Health) as a companion diagnostic for amivantamab-vmjw.

Read FDA press release