Libtayo First Immunotherapy Approved for Advanced Cutaneous Squamous-Cell Carcinoma

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates


On September 28, 2018, the FDA approved cemiplimab-rwlc injection (Libtayo; Regeneron), a new immune checkpoint inhibitor, for the treatment of patients with metastatic cutaneous squamous-cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for surgery or radiation.

Cemiplimab-rwlc is a new PD-1/PD-L1 inhibitor and the 6th checkpoint inhibitor approved by the FDA. The FDA approved cemiplimab-rwlc using its priority review and has granted it a breakthrough therapy designation. This approval marks the first drug approved by the FDA specifically for patients with advanced CSCC, the second most common (after basal-cell carcinoma) skin cancer.

“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 6 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 advanced CSCC,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “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.”

This approval was based on 2 open-label clinical trials that included 108 patients—75 with metastatic CSCC and 33 with locally advanced CSCC. The primary end point in each study was objective response rate (ORR). The ORR was 47.2% in patients who received cemiplimab-rwlc. At the time of data analysis, the responses were ongoing in the majority of the patients who had a positive objective response.

Cemiplimab-rwlc must be provided to the patient with a Medication Guide that describes the serious warning associated with this drug. Like all immunotherapies, this medication can cause severe immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and dermatologic and kidney problems. The most common (≥20%) adverse events reported with cemiplimab-rwlc in clinical trials were fatigue, rash, and diarrhea.