Regeneron and Sanofi receive FDA’s breakthrough therapy status for CSCC treatment with cemiplimab


US-based Regeneron Pharmaceuticals and French company Sanofi have received breakthrough therapy designation status for cemiplimab (REGN2810) from the US Food and Drug Administration (FDA) to treat cutaneous squamous cell carcinoma (CSCC).

The FDA status will enable the companies to use cemiplimab for the treatment of adults with metastatic CSCC or adults with locally advanced and unresectable CSCC.

CSCC is the second deadliest form of skin cancer after melanoma.

Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 currently being co-developed by Regeneron and Sanofi under a global collaboration agreement.

At present, the two companies are carrying out a potentially pivotal, single-arm, open label Phase II clinical trial for cemiplimab known as EMPOWER-CSCC 1, which involves patients for both metastatic CSCC and locally advanced and unresectable CSCC.

"The FDA status will enable the companies to use cemiplimab for the treatment of adults with metastatic CSCC or adults with locally advanced and unresectable CSCC."

While awaiting study results, the companies expect to submit a biologics licence application (BLA) for cemiplimab with the FDA in the first quarter of next year.

When detected at an early stage, CSCC has a good prognosis, but can prove to be significantly difficult to be treated when the disease progresses to advanced stages.

Patients can be disfigured due to multiple surgeries carried out to remove CSCC tumours on the head, neck and other parts of the body.

The disease is the second most common type of skin cancer in the US and is responsible for the cause of most deaths among non-melanoma skin cancer patients.

The Regeneron and Sanofi treatment is currently under clinical development, and its safety and efficacy has not yet been completely investigated by any regulatory authority.