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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

"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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.