New Immunotherapeutic Approved for Common Skin Cancer

The FDA decision makes cemiplimab-rwlc the first-ever treatment approved specifically for treating squamous cell carcinoma.

Source: National Cancer Institute

The U.S. Food and Drug Administration (FDA) recently approved a new immunotherapeutic called cemiplimab-rwlc (Libtayo) for treating patients with a type of skin cancer called cutaneous squamous cell carcinoma.

Cemiplimab-rwlc is intended for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma that cannot be treated with curative surgery or curative radiation.

Cutaneous squamous cell carcinoma is the second most common type of skin cancer. There are about 700,000 cases of the disease diagnosed each year in the United States, according to the FDA.

Most patients with cutaneous squamous cell carcinoma are cured by surgery and/or radiation, so the advanced disease is rare. However, if it does occur, it can be difficult to treat and there were no therapeutics approved specifically to treat it before the approval of cemiplimab-rwlc.

The approval of cemiplimab-rwlc was based on results from two small clinical trials, according to the FDA statement. Overall, 47.2 percent of the 108 patients who received it responded to the treatment, meaning their tumors had shrunk significantly or disappeared. Most the patients who had tumor shrinkage or disappearance were still experiencing this benefit at the time the data were collected.

Cemiplimab-rwlc is a type of immunotherapy known as a checkpoint inhibitor. It is the seventh checkpoint inhibitor approved by the FDA, and the sixth to target the PD-1/PD-L1 pathway that puts the brakes on cancer-fighting immune cells called T cells. Two researchers whose work was critical to the development of these immunotherapeutics, which have revolutionized the treatment of at least 13 types of cancer and the treatment of solid tumors positive for either the microsatellite instability-high or mismatch-repair deficient biomarkers were recognized in October for their pioneering work in cancer immunotherapy with the 2018 Nobel Prize in Physiology or Medicine.

Read more and watch a video about the work of Nobel Prize-winning researcher and Fellow of the AACR Academy James P. Allison, PhD, here.


The FDA approval was rendered on Sept. 28, 2018.