FDA approves Pemazyre to treat cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion.- Incyte Corpn.
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Taiho Oncology and Taiho Pharmaceutical announced that the FDA has approved Lytgobi tablets for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Taiho Pharmaceutical Co., Ltd. announced that it has submitted to the Japanese Ministry of Health, Labour and Welfare a new drug application for futibatinib (TAS-120), a FGFR inhibitor as a treatment for previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions.
Innovent Biologics announced that the National Medical Products Administration (NMPA) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.