Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), which is one of the most commonly diagnosed skin cancers.
Libtayo, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death protein-1 (PD-1) is being jointly developed by Sanofi and Regeneron.
The monoclonal antibody has been approved for the treatment of patients who are not eligible for either curative radiation or curative surgery. The recommended dose as per Libtayo EMA approval is 350mg for every three weeks with the drug to be IV infused over 30 minutes with treatment to be continued until disease progression or unacceptable toxicity.
Libtayo EMA approval was driven by the data from an open-label, non-randomized phase-2 clinical trial called EMPOWER-CSCC-1. The approval of the skin cancer drug was also on the basis of a couple of advanced CSCC expansion cohorts from an open-label, non-randomized phase 1 clinical trial (Study 1423).
Commenting on Libtayo EMA approval, Axel Hauschild – investigator in the CSCC clinical program and Professor and Head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Germany, said “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.
“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.”
Sanofi and Regeneron, as part of the conditional approval, plan to add a new patient group to the EMPOWER-CSCC-1 clinical trial to further support Libtayo’s benefit-risk profile and report the outcome results to the European Medicines Agency (EMA).
Last year, the two companies bagged Libtayo FDA approval for the treatment for the same indication. The monoclonal antibody is also approved in Brazil and Canada for the same indication of metastatic or locally advanced cutaneous squamous cell carcinoma in adult patients who are not eligible for curative surgery or curative radiation.
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