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On July 9th, Innovent announced that NMPA has officially accepted the application for the fibroblast growth factor receptor (FGFR) 1/2/3 inhibitor (pemigatinib tablet) for the market, for at least one systemic treatment in the past, and Adult patients with advanced, metastatic or unresectable cholangiocarcinoma with FGFR2 fusion or rearrangement confirmed by testing
Cholangiocarcinoma is a malignant tumor that originates from bile duct epithelial cells.
FGFR gene mutations exist in many types of human tumors, mainly through FGFR gene amplification, mutation, chromosomal translocation, and ligand-dependent activation of FGFR signal abnormalities
The new indication application submitted to NMPA is based on a Phase II, open-ended, single-arm, multi-center study
In the FIGHT-202 study, a total of 108 patients with cholangiocarcinoma with FGFR2 fusion or rearrangement were enrolled and received pemigatinib 13.
A total of 147 subjects were included in the safety analysis, and the results showed that pemigatinib was well tolerated
Pemigatinib was originally developed by Incyte.
In April 2020, the FDA accelerated the approval of Incyte's Pemazyre for the treatment of previously treated adult advanced/metastatic or unresectable FGFR2 gene fusion/rearranged cholangiocarcinoma
In Japan, Pemazyre is approved to treat patients who have unresectable biliary tract cancer (BTC) with the FGFR2 fusion gene and have worsened after chemotherapy
