Libtayo approved for advanced CSCC in Europe

Libtayo has been approved in Europe 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 (cemiplimab) 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 EU.

The approval from the European Commission is based on data from the pivotal, open-label, multi-centre, non-randomised Phase 2 trial known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-centre, open-label, non-randomized Phase 1 trial (Study 1423).

These trials provide the largest prospective clinical data set evaluating a systemic therapy in patients with advanced CSCC to date.

“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,” said Axel Hauschild, an investigator in the pivotal CSCC clinical program and Professor and Head of the Interdisciplinary Skin Cancer Centre 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.”

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Related news