Libtayo (cemiplimab): The only EU approved treatment for advanced CSCC

This is a summary of Sanofi's press release.

In a press release on 1 July 2019, the French pharmaceutical manufacturer Sanofi, announced that, 'The European Commission (EC) has granted conditional marketing authorization for Libtayo (cemiplimab) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.'

This treatment is the only one approved for this purpose in the European Union (EU). The conditional approval acknowledges the extreme unmet need for those with this form of skin cancer. 'CSCC is one of the most common skin cancers worldwide and is especially difficult to treat in advanced stages'. According to past data sourced in the press release, patients with advanced CSCC have a one-year life expectancy. Additionally, the incidence is estimated to be on the increase in some European countries.

This treatment is classed as a 'fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1)'. It is delivered as an intravenous infusion with a recommended dose of 350 mg every three weeks.

The development of Libtayo (cemiplimab) is the result of a global collaboration agreement by pharmaceutical manufacturers Sanofi and Regeneron. Libtayo (cemiplimab) is already approved in the US, Canada and Brazil, and is being investigated for other types of cancers such as non-small cell lung cancer, basal cell carcinoma, cervical cancer, squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma.

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