Regulatory Affairs

Regeneron, Sanofi get FDA breakthrough therapy status for skin cancer drug cemiplimab

PBR Staff Writer Published 11 September 2017

Regeneron Pharmaceuticals and Sanofi have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for cemiplimab (REGN2810) to treat advanced cutaneous squamous cell carcinoma (CSCC).

The approval has been granted for cemiplimab to treat adults with metastatic CSCC and adults with locally advanced and unresectable CSCC.

CSCC is claimed to be the second most common type of skin cancer in the US. It is difficult to treat when it progresses to advanced stages.

Cemiplimab, which is an investigational human and monoclonal antibody targeting PD-1, has been discovered by using Regeneron's VelocImmune technology that helps to generate optimized fully-human antibodies.

Under a global collaboration agreement, cemiplimab is being developed by Regeneron and Sanofi.

Earlier, the firms reported positive and preliminary results for cemiplimab from two expansion cohorts, which included 26 advanced CSCC patients in a phase 1 study of around 400 patients.

Empower-CSCC 1 is a phase 2, pivotal, single-arm and open-label clinical trial of cemiplimab, which is currently recruiting patients with metastatic CSCC and locally advanced and unresectable CSCC

Based on trial data results, the companies intend to submit a biologics license application to the FDA for cemiplimab in the first quarter of 2018.

Currently, cemiplimab is under clinical development, and its safety and efficacy has not been fully assessed by any regulatory authority.

In June, Sanofi and Regeneron secured approval from the European Commission (EC) for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients.

Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.