What's Happening?
Regeneron's Libtayo has received FDA approval as an adjuvant treatment for adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation therapy. This approval extends Libtayo's use beyond its current indications for advanced CSCC, basal cell carcinoma, non-small cell lung cancer, and cervical cancer. The approval is based on the C-POST study, which demonstrated a significant reduction in disease recurrence or death for high-risk CSCC patients treated with Libtayo compared to placebo.
Why It's Important?
The approval of Libtayo for adjuvant use in CSCC represents a significant advancement in skin cancer treatment, providing a new option for patients at high risk of recurrence. This development could improve patient outcomes and reduce the burden of advanced disease recurrences. It also highlights Regeneron's commitment to addressing unmet needs in non-melanoma skin cancer through innovative research, potentially influencing future treatment standards.
What's Next?
Regeneron has submitted Libtayo for approval in Europe for the adjuvant CSCC indication, with a decision expected in the first half of 2026. The company will continue to explore additional indications for Libtayo, potentially expanding its use in other cancer types. The approval may also encourage further research into adjuvant therapies for skin cancer.
