RYBREVANT (amivantamab) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by a validated test, whose disease has progressed on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.