Sanofi cleared with “if” to market Libtayo in Europe

The European Commission (EC) has granted conditional marketing authorization for Libtayo to 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).

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 Center at the University Hospital Schleswig-Holstein in Kiel, Germany.

He said that the 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.

The EC approval is based on data from the pivotal, open-label, multi-center, non-randomized Phase 2 trial known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase 1 trial (Study 1423), Sanofi said, who is developibg Libtayo jointly with Regeneron.

The “if” part

The conditional approval recognizes the extreme unmet need in advanced CSCC. 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), Sanofi explained. As is standard practice for conditional approvals, the EMA reviews new information at least every year and updates product labeling as necessary.