FDA Approves Libtayo, The First Immunotherapy for Advanced Basal Cell Carcinoma

The Food and Drug Administration (FDA) granted full approval to Libtayo (cemiplimab-rwlc) for the treatment of patients with locally advanced basal cell carcinoma (BCC), according to the agent’s manufacturers, Sanofi and Regeneron.

The agency also granted Libtayo accelerated approval for the treatment of patients with advanced BCC who were previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI was not appropriate. This drug, according to the manufacturers, is now the first immunotherapy for this patient population.

“Today’s FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma,” Dr. Karl Lewis, a professor in the division of medical oncology at the University of Colorado, said in the company-issued press release. “Advanced basal cell carcinoma is a persistent, painful and highly disfiguring cancer. While the primary systemic treatment options are hedgehog inhibitors, many patients will eventually progress on or become intolerant to this therapy. With Libtayo, these patients now have a new immunotherapy option that has demonstrated clinically meaningful and durable anti-tumor responses in locally advanced BCC.”

The agency’s decision for the full approval was based on results of a primary analysis, and the accelerated approval was granted based on data from an interim analysis showing the drug’s impact on tumor response rates and its durability of response. The manufacturers noted that additional data from the trial demonstrating its benefit may be needed to ensure continued approval of Libtayo for this patient population.

The most common form of skin cancer in the United States, basal cell carcinoma accounts for approximately 2 million new cases of cancer each year. The disease is usually easily treated if it is detected early; however, disease that has penetrated deeper into a person’s tissue (locally advanced) or spread elsewhere (metastatic) is harder to treat.

“With today’s approval, Libtayo is now approved for both advanced cutaneous squamous cell and basal cell carcinomas, building a strong foundation in dermato-oncology,” Regeneron’s senior vice president of translation and clinical services and oncology, Dr. Israel Lowy, said in the release.