A speedy FDA offers lightning review and quick OK for the latest PD-1 from Regeneron and Sanofi
The FDA really didn’t need until the end of October to decide on whether it wanted to approve cemiplimab, the world’s 6th PD-1/L1 from Sanofi and Regeneron. Regulators flagged it through on Friday evening, happy to see the field crowd up as a top collaboration team cruised to a win ahead of a priority review deadline.
The drug will be sold as Libtayo for advanced cutaneous squamous cell carcinoma. Investigators came up with a 46.3% ORR for advanced CSCC in their key study and plan to sell the therapy with a wholesale acquisition cost of $9,100 per three-week treatment cycle. Patients will be eligible for copay support.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.