Cemiplimab-rwlc Approved for Advanced Cutaneous Squamous Cell Carcinoma in European Union
Posted: Thursday, July 11, 2019
The European Commission (EC) has recently granted conditional marketing authorization for cemiplimab-rwlc (Libtayo) in the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiationtherapy. Cemiplimab-rwlc is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 and is the only treatment approved for advanced cutaneous squamous cell carcinoma in the European Union.
The EC approval was based on data from the pivotal, open-label, mult-center, nonrandomized phase II EMPOWER-CSCC-1 trial (ClinicalTrials.gov identifier NCT02760498). These data are supported by two advanced cutaneous squamous cell carcinoma expansion cohorts from a multicenter, open-label, nonrandomized phase I trial. These trials provide the largest prospective clinical data set evaluating a systemic therapy in patients with advanced cutaneous squamous cell carcinoma to date.
The recommended dose of cemiplimab-rwlc is 350 mg every 3 weeks administered by intravenous infusion over 30 minutes.
Cemiplimab-rwlc was initially approved for intravenous use in the United States in September 2018 for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation therapy.
