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.

Endpoints News

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.