The U.S. Food and Drug Administration granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
The FDA granted approval of Pemazyre to Incyte Corporation.
Cholangiocarcinoma is a rare form of cancer that forms in bile ducts, which are slender tubes that carry the digestive fluid bile from the liver to gallbladder and small intestine. Today’s approval is for patients with cholangiocarcinoma that is locally advanced or metastatic and who have tumors that have a fusion or other rearrangement of a gene called fibroblast growth factor receptor 2 (FGFR2).
At diagnosis, a majority of patients with cholangiocarcinoma have advanced disease, meaning that the disease is no longer treatable with surgery. For these patients, until today, there have been no FDA-approved therapies; a combination of chemotherapy drugs has been the standard initial treatment...
Full text at GMPnews.Net