FDA Approves Libtayo to Treat Second Most Common Skin Cancer

Last week, the FDA granted approval to immune checkpoint inhibitor cemiplimab-rwlc, to be sold as Libtayo, for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC), or in patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.

CSCC is the second most common form of skin cancer and is responsible for nearly 7000 deaths each year in the United States. To date, the cancer accounts for an estimated 20% of all skin cancers in the United States, with the number of newly diagnosed patients expected to rise on an annual basis.

Developed in conjunction by Regeneron Pharmaceuticals and Sanofi, cemiplimab-rwlc is a monoclonal antibody that targets the immune checkpoint receptor PD-1. According to Regeneron, this is the first and only treatment specifically approved and available for advanced CSCC in the United States.

The “FDA decision is great news for patients with advanced CSCC, who previously had no approved treatment options. … Libtayo is an important new immunotherapy option for US physicians to help address a significant unmet need in this patient group,” said Michael R. Migden, MD, lead investigator in the CSCC clinical program and professor in the departments of dermatology and head and neck surgery at The University of Texas MD Anderson Cancer Center.

Cemiplimab-rwlc was evaluated under the FDA’s Priority Review pathway and was granted Breakthrough Therapy Designation status for advanced CSCC in 2017. The recommended dosage of cemiplimab-rwlc is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until disease progression or unacceptable toxicity.

In the United States, the wholesale acquisition cost of the treatment is $9100 per 3-week treatment cycle; however, Regeneron and Sanofi noted that “the actual costs to patients are generally anticipated to be lower as the list price does not reflect insurance coverage, copay support, or financial assistance from patient support programs.”

“In the US, CSCC accounts for 1 in 5 skin cancers, and the number of new diagnoses is increasing. We believe Libtayo has the potential to make a difference for US patients with advanced CSCC, as it helps to fill a critical gap in treatment options,” said Olivier Brandicourt, MD, CEO, Sanofi.