CHMP recommends approval of Libtayo for cutaneous squamous cell carcinoma

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Libtayo (cemiplimab), from Sanofi/Regeneron. The CHMP recommended its conditional approval for the treatment of adult patients 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). If approved, Libtayo would be the first and only treatment approved for certain patients with advanced CSCC in the European Union.

The CHMP opinion is based on data from the pivotal, open-label, multi-center, non-randomized Phase II EMPOWER-CSCC-1 trial (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase I trial. Together, the trials represent the largest prospective dataset of advanced CSCC patients. As part of the conditional approval, Sanofi and Regeneron will need to provide additional data from EMPOWER-CSCC-1, including results from a newly added group to the trial, to further confirm the benefit-risk profile of Libtayo. The European Commission is expected to make a final decision on the application for Libtayo in the coming months.