FDA Approves Incyte’s Pemazyre? (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

發(fā)布時(shí)間： 2020-04-30 閱讀：740次

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Apr. 17, 2020-- Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre? (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Pemazyre was approved under accelerated approval based on overall response rate and duration of response (DOR). Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor. The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in North America and Europe. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16% of patients

“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,”1,2 said Ghassan Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center. “It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”