Press Releases

For Trade and Medical Media Only

Availability of Lytgobi (futibatinib) marks the first medicine launched by
Taiho Oncology Europe

BAAR, Switzerland, 1 August 2024 – Taiho Oncology Europe GmbH announced today the introduction of Lytgobi® (futibatinib), a novel irreversibly binding fibroblast growth factor receptor (FGFR) inhibitor,¹ in France. This milestone follows the conditional marketing authorisation in the European Union for 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.² The Haute Autorité de Santé (HAS) has approved funding for Lytgobi more specifically for patients presenting with intrahepatic CCA and non-eligible to receive FOLFOX chemotherapy.³

For Trade and Medical Media Only

Availability of Lytgobi (futibatinib) marks the first medicine launched by
Taiho Oncology Europe

BAAR, Switzerland, 1 August 2024 – Taiho Oncology Europe GmbH announced today the introduction of Lytgobi® (futibatinib), a novel irreversibly binding fibroblast growth factor receptor (FGFR) inhibitor,¹ in Spain. This milestone follows the conditional marketing authorisation in the European Union for 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.²

For Trade and Medical Media Only

Availability of Lytgobi (futibatinib) marks the first medicine launched by

Taiho Oncology Europe

BAAR, Switzerland, 11 June 2024 – Taiho Oncology Europe GmbH announced today the introduction of Lytgobi^® (futibatinib), a novel irreversibly binding fibroblast growth factor receptor (FGFR) inhibitor,¹ in Germany. This milestone follows the conditional marketing authorisation in the European Union for 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.²

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.

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.