Health Canada issues Notice of Compliance with Conditions for Libtayo (cemiplimab), the first and only biologic for the treatment of advanced cutaneous squamous cell carcinom

Sanofi

11 April 2019 - Cutaneous squamous cell carcinoma is the second most common skin cancer in Canada.

Sanofi Genzyme announced today that Health Canada has issued a Notice of Compliance with conditions for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. The market authorisation is conditional pending the results of studies to verify its clinical benefit. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only biologic treatment specifically approved and available for advanced CSCC in Canada.

The Health Canada Notice of Compliance with conditions of Libtayo was based on a combined analysis of data from an open-label, multi-center, non-randomized Phase 2 trial known as EMPOWER-CSCC-1 (Study 1540) and two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase 1 trial (Study 1423). Together, the trials represent the largest prospective data set in advanced CSCC.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , Canada