RYBREVANT (Janssen-Cilag Pty Ltd)

RYBREVANT has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.

The decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory study.