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LIBTAYO (Sanofi-Aventis Australia Pty Ltd)
Product name
LIBTAYO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
43 (255 working days)
Active ingredients
cemiplimab
Registration type
EOI
Indication
Disease and setting
LIBTAYO (concentrate for solution for infusion) as monotherapy now also has provisional approval in Australia for the treatment of adult patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
The decision to approve the mBCC indication has been made on the basis of objective response rate (ORR) and duration of response from a single arm clinical study. 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