LIBTAYO (Sanofi-Aventis Australia Pty Ltd)
Product name
LIBTAYO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days
Active ingredients
cemiplimab
Registration type
EOI
Indication
LIBTAYO in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of patients with NSCLC whose tumours have no EGFR, ALK or ROS1 aberrations and is:
- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.