Sanofi: EMA to review marketing authorisation of cemiplimab
(CercleFinance.com) - Sanofi has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.
This application for marketing authorisation is based on the results of a phase II clinical pivot trial - single group (EMPOWER-CSCC 1), as well as those obtained from two cohorts of expansion of a phase I study.
Cemiplimab is developed by Sanofi and Regeneron as part of a comprehensive collaboration agreement. It is currently in clinical development, and no regulatory agency has yet fully assessed its safety and effectiveness profiles.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
This application for marketing authorisation is based on the results of a phase II clinical pivot trial - single group (EMPOWER-CSCC 1), as well as those obtained from two cohorts of expansion of a phase I study.
Cemiplimab is developed by Sanofi and Regeneron as part of a comprehensive collaboration agreement. It is currently in clinical development, and no regulatory agency has yet fully assessed its safety and effectiveness profiles.
Copyright (c) 2018 CercleFinance.com. All rights reserved.