FDA approves treatment for metastatic cutaneous squamous cell carcinoma

Bloomberg News (9/28) reported the Food and Drug Administration approved Regeneron Pharmaceuticals Inc.’s and Sanofi’s Libtayo (cemiplimab-rwlc) for the treatment of “a deadly form of skin cancer.” The article points out that “it’s the first drug to come out of the companies’ 2015 partnership to research therapies that use the body’s immune system to fight various malignancies.”

Reuters (9/28, Babu) reported the Food and Drug Administration approved Sanofi SA’s and Regeneron Pharmaceuticals Inc.’s Libtayo (cemiplimab-rwlc) for the treatment of metastatic cutaneous squamous cell carcinoma “in patients whose condition has not improved following surgery or chemotherapy.” The article added that “metastatic cutaneous squamous cell carcinoma is the second-most common form of skin cancer, which accounts for an estimated 7,000 deaths in the United States each year.”

According to MedPage Today (9/28, Ingram), Richard Pazdur, M.D., the director of the FDA’s Oncology Center of Excellence, said in a statement, “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.” Dr. Pazdur added, “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 PD-1/PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now cutaneous squamous cell carcinoma.