Pemigatinib treats advanced bile tube cancer with FGFR2 fusion or rearmissing, chMP said positively

Bile tube cancer is a rare form of cancer that forms in the bile tube.
is classified according to its source: intra-hepatic bile tube cancer (iCCA) occurs in the bile tube inside the liver, and ex-liver bile tube cancer occurs in the bile tube outside the liver.
in Europe, the incidence of bile tube cancer is between 6,000 and 8,000.
FGFR2 fusion or rearring occurs almost exclusively in iCCA, with an occurrence rate of about 10% to 16%.
pharmaceutical company Incyte recently announced that the European Medicines Agency (EMA) Human Medicines Commission (CHMP) has a positive opinion on the treatment of partially advanced or metastatic bile tube cancer that cannot be removed by pemigatinib and recommends approval for listing.
these patients are recurring or incurable patients with fibroblast growth factor complex 2 (FGFR2) fusion or rearm.
for patients, CHMP's positive opinion is a key milestone for bile tube cancer," said Peter Langmuir, vice president of Incyte, a research group.
following FDA approval of Pemazyre ®), we are pleased to offer the first targeted therapy for these patients in Europe."
CHMP's opinion is based on data from theFIGHT-202 study, which assessed the safety and effectiveness of pemigatinib in adult patients with previously treated, localized late stage or metastatic bile tube cancer.
if approved, pemigatinib will be the first targeted treatment in the EU for patients with non-removable localized advanced or metastatic bile tube cancer who are fused or rearmed with FGFR2.