Regeneron scores in adjuvant skin cancer

Regeneron has had its ups and downs in 2025, but this time the company has landed some good news. The FDA has approved Libtayo as adjuvant therapy for patients with cutaneous squamous cell carcinoma at high risk of recurrence following surgery and radiation. Notably, Regeneron left Catalent’s Indiana facility out of the BLA; according to an FDA inspection report, this plant was found to be contaminated with mammalian hair and other particulates. Issues at the site led to a second complete response letter for Regeneron’s CD20-targeting T-cell engager odronextamab in August, in follicular lymphoma. The project had previously been rejected by the FDA in March 2024, in follicular lymphoma and diffuse large B-cell lymphoma, because confirmatory trials weren't sufficiently enrolled. While it’s unclear what this means for Regeneron’s collaboration with Catalent, which was acquired by Novo Nordisk last year, it’s possible that the company wasn’t willing to risk another setback. The adjuvant nod, meanwhile, comes with no immediate competition in sight. Merck & Co.’s Keytruda stumbled in its Keynote-630 study, and for now no other contenders appear to be chasing this indication.

Regeneron’s 2025 regulatory journey

Source: OncologyPipeline.