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Libtayo becomes first EU-approved therapy for advanced cutaneous squamous cell carcinoma

Published on 02/07/19 at 10:59am

The European Commission has revealed that it has decided to award approval, albeit conditionally, to Sanofi and Regeneron’s Libtayo (cemiplimab) in the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adult patients who are not eligible for curative surgery or curative radiation.

The EC’s decision took into account the unmet need in the indicated disease, and was based on data drawn from the largest prospective data set available in advanced CSCC – a set comprising data from a non-randomised Phase 2 trial and two advanced CSCC expansion cohorts from a non-randomised Phase 1 trial.  

As part of the conditional approval, Sanofi and Regeneron have confirmed they will introduce a new patient group into an ongoing trial to further assess the efficacy of Libtayo, as per the EMA’s request.

“With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer who cannot be cured by surgery or radiation,” explained Dr Axel Hauschild, investigator in the trials and Professor and Head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Kiel, Germany. “Results from the Libtayo pivotal trial are very encouraging and demonstrated substantial and durable responses following Libtayo treatment, including in the elderly and regardless of PD-L1 expression levels.”

Matt Fellows

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