LIBTAYO (cemiplimab) is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

LIBTAYO has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for LIBTAYO please refer to Health Canada’s Notice of Compliance with conditions - drug products website. Marketing authorization with conditions is based on tumour response rate and durability of response. An improvement in overall survival (OS) or progression free survival (PFS) has not yet been established in this single-arm study.