LIBTAYO (Sanofi-Aventis Australia Pty Ltd)
Product name
LIBTAYO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
203 (255 working days)
Active ingredients
cemiplimab
Registration type
EOI
Indication
Basal Cell Carcinoma
LIBTAYO (concentrate for solution for infusion) as monotherapy is now also indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
Non-Small Cell Lung Cancer
LIBTAYO as monotherapy is now also indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 tumour proportion score (TPS) ≥50% as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have:
- locally advanced NSCLC and who are not candidates for surgical resection or definitive chemoradiation, or
- metastatic NSCLC.