EXKIVITY (Takeda Pharmaceuticals Australia Pty Ltd)

EXKIVITY has provisional approval in Australia for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an exon 20 insertion mutation of the epidermal growth factor receptor (EGFR), who have received prior 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.