Sanofi, Regeneron's Libtayo scores UK watchdog's approval in common form of skin cancer

Those in the U.K. with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) and are not eligible for surgery or radiation finally have fully-funded treatment option.

On Wednesday, England’s National Institute for Health and Care Excellence (NICE) signed off on Sanofi and Regeneron’s Libtayo for the tough-to-treat skin cancer, allowing patients in the U.K. fully funded access to the drug.

Libtayo has been available in the U.K. since 2019 under the Cancer Drugs Fund (CDF). Officials established that program to quickly give patients access to new treatments under spending limitations. Real-world data gathered since has justified the cost-effectiveness of the drug, NICE said.

Helping sway NICE was the Empower-CSCC-1 phase 2 trial of 816 patients which showed Libtayo’s ability to combat solid malignancies.

CSCC is the second-most common form of skin cancer in the U.K., accounting for 23% of all non-melanoma types, and is on the rise. When CSCC is diagnosed late, it is tough to treat as the median overall survival rate is less than two years for metastatic cases.

Libtayo was approved in the United States four years ago for CSCC. In February of 2021, two more blessings came from the FDA—for advanced basal cell carcinoma and then for first-line advanced non-small cell lung cancer with PD-L1 expression of 50% or greater.