Regulatory Affairs

EMA to review cemiplimab for treatment of advanced cutaneous squamous cell carcinoma

Published 04 April 2018

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.

Advanced CCSC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1).

The MAA for cemiplimab is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery.

Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017 American Society of Clinical Oncology Annual Meeting. Updated results from both clinical trials are being submitted for presentation at upcoming medical congresses.

Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. 

Cemiplimab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Cutaneous squamous cell carcinoma (CSCC) is one of the most common cancers worldwide, with the number of newly diagnosed cases expected to rise annually.

Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer, and there are no EMA-approved treatments for advanced CSCC.

Source: Company Press Release