Posted by Michael Wonder on 17 Apr 2020
FDA approves first targeted treatment for patients with cholangiocarcinoma, a cancer of bile ducts
17 April 2020 - Today, the U.S. FDA granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
Pemazyre’s approval was based on the results of a clinical trial that enrolled 107 patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement who had received prior treatment.
The FDA granted this application priority review and breakthrough therapy designation, which expedites the development and review of drugs that are intended to treat a serious condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
