July 1, 2019 - 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.
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC in the European Union (EU).
CSCC is one of the most commonly diagnosed skin cancers worldwide, and its incidence is estimated to be substantially increasing in some European countries. Although the vast majority of patients with CSCC have a good prognosis when discovered early, the cancer can be especially difficult to treat when it progresses to advanced stages.
Advanced CSCC includes both patients with locally advanced disease (where the cancer cannot be cured by surgery and/or radiation) and patients with metastatic disease (when the cancer spreads to other parts of the body). Based upon historical data, patients with advanced CSCC have a life expectancy of approximately one year.
As part of the conditional approval, Sanofi and Regeneron will add a new patient group to EMPOWER-CSCC-1 to further support the benefit-risk profile of Libtayo, and report the results to the European Medicines Agency (EMA).
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