AI-Generated Summary

The FDA has granted approval to Regeneron's PD-1 inhibitor, Libtayo (cemiplimab-rwlc), as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) post-surgery and radiation. This decision, under Priority Review, is supported by pivotal Phase 3 C-POST trial data demonstrating a 68% reduction in disease recurrence or death risk. An additional regulatory application for Libtayo is currently under review in the European Union.

In a nutshell

This approval expands Libtayo's utility in a high-unmet-need population, reinforcing Regeneron's oncology pipeline and offering a significant new adjuvant option for high-risk CSCC patients. It underscores the continued importance of PD-1 inhibitors in cancer treatment and highlights successful navigation of the regulatory pathway.

Source: Benzinga