Posted by Michael Wonder on 28 Apr 2019
CHMP issues positive opinion for Libtayo (cemiplimab) in advanced cutaneous squamous cell carcinoma
26 April 2019 - Currently no approved treatments in the European Union for advanced cutaneous squamous cell carcinoma.
The EMA's CHMP has adopted a positive opinion for the marketing authorization of Libtayo (cemiplimab). 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.
The CHMP opinion is based on data from the pivotal, open-label, multi-center, non- randomized Phase 2 EMPOWER-CSCC-1 trial (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomised Phase 1 trial. Together, the trials represent the largest prospective dataset of advanced CSCC patients.
