Press Releases

2 Press Releases match your criteria.

  Date Press Release
View 2023-07-04 European Commission Grants Conditional Marketing Authorization for Taiho’s LYTGOBI® Tablets for the Treatment of Adults With Cholangiocarcinoma

LYTGOBI is the first irreversibly binding FGFR inhibitor in the European Union for use in the treatment of patients with cholangiocarcinoma

ZUG, Switzerland, 4 July 2023 - Taiho Oncology Europe GmbH and Taiho Pharmaceutical Co., Ltd., announced today that the European Commission has granted conditional marketing authorization for LYTGOBI® (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

View 2023-04-27 CHMP ISSUES POSITIVE OPINION FOR FUTIBATINIB FOR THE TREATMENT OF ADULTS WITH CHOLANGIOCARCINOMA

ZUG, Switzerland,27 April 2023– Taiho Oncology Europe GmbH and Taiho Pharmaceutical Co., Ltd. announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization (CMA) of futibatinib for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.