LIBTAYO (Sanofi-Aventis Australia Pty Ltd)
Product name
LIBTAYO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 working days (255)
Active ingredients
cemiplimab
Registration type
NCE/NBE
Indication
LIBTAYO (concentrate for solution for infusion) as monotherapy has provisional approval in Australia for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration