EXKIVITY (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
EXKIVITY
Date registered
Evaluation commenced
Decision date
Approval time
199 (255 working days)
Active ingredients
mobocertinib succinate
Registration type
NCE/NBE
Indication
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.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration