Innovent's FGFR inhibitor approved for marketing

Article source: Medical Cube Info

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On April 6, the NMPA approved the marketing application of Innovent Bio-Fibroblast Growth Factor Receptor (FGFR) 1/2/3 inhibitor pemigatinib for at least one prior systemic therapy , and adult patients with advanced, metastatic, or unresectable cholangiocarcinoma with confirmed FGFR2 fusions or rearrangements

Cholangiocarcinoma is a malignant tumor originating from bile duct epithelial cells.

FGFR gene variants exist in various types of human tumors, mainly through FGFR gene amplification, mutation, chromosomal translocation, and ligand-dependent activation of FGFR signaling abnormalities

Pemigatinib was originally developed by Incyte.

In April 2020, the FDA granted accelerated approval to Incyte's Pemazyre for the treatment of previously treated adults with advanced/metastatic or unresectable FGFR2 gene fusion/rearranged cholangiocarcinoma

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with an FGFR2 fusion gene that worsens after chemotherapy