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.