![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
The item has been added to your shopping cart.
Home » FDA Approves Incyte’s Pemazyre for Rare Cancer
FDA Approves Incyte’s Pemazyre for Rare Cancer
The FDA granted accelerated approval to Incyte’s Pemzayre for adults with previously treated, advanced cholangiocarcinoma, a rare bile duct cancer.
The approval was based on the results of a clinical trial of 107 patients that showed an overall response rate of 36 percent and a 2.8 percent complete response rate.
As a post approval requirement, Incyte must conduct a randomized trial to demonstrate an improvement in progression-free survival or overall survival.
Upcoming Events
-
21Oct