Sanofi, Regeneron's Libtayo hits hot streak with EU green light, NICE backing

Sanofi and Regeneron’s Libtayo is two for two in the last two days-with European officials, that is. One day after the European Commission cleared the PD-1 drug to treat cutaneous squamous cell carcinoma, England’s cost watchdog signed off on an access agreement for the product in adults whose disease can’t be treated with surgery or radiotherapy. But it’s not an outright win for Libtayo at the National Institute for Health and Care Excellence (NICE). The cost-effectiveness gatekeeper will add the product to its Cancer Drugs Fund rather than cover it for routine use on the National Health Service. And as usual, the gatekeeper has some conditions. Patients should receive Libtayo until their disease progresses or they reach the two-year mark-whichever comes sooner, NICE said.