FDA Approves Injection for Metastatic Cutaneous Squamous Cell Carcinoma

The FDA granted approval to an injection for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Cemiplimab-rwic (Libtayo; Regeneron Pharmaceuticals) injection is now approved for intravenous use and marks the first FDA approval of a drug for advanced CSCC.

This approval is based on safety and efficacy results from two open label clinical trials in which a total of 108 patients—75 with metastatic disease and 33 with local-advanced disease—were included in the efficacy evaluation. The primary endpoint was objective response rate. Results showed that 47.2% of patients who received cemiplimab-rwic experienced tumor shrinkage or had their tumors disappear, and a majority of these patients had ongoing responses at the time of data analysis.

Common side effects of cemiplimab-rwic include fatigue, rash, and diarrhea. Serious adverse reactions include the risk of immune-mediated adverse reactions such as lung problems (pneumonitis), intestinal problems (colitis), liver problems (hepatitis), hormone gland problems (endocrinopathies), skin (dermatologic) problems, and kidney problems.

“We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the the PD-1 / PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now advanced CSCC,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release (September 28, 2018).

“This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients,” he added.—Janelle Bradley