Taiho Oncology Europe GmbH and Taiho Pharmaceutical Co., Ltd., announced 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.
CCA is an aggressive cancer of the bile ducts of the liver. While rare – in Europe, approximately 6.000-8.000 people are diagnosed with CCA1 – this disease is associated with poor outcomes and is growing in prevalence worldwide2, underscoring the need for new treatment options.
The European Commission's conditional marketing authorization for LYTGOBI is based on data from the aforementioned FOENIX-CCA2 trial, a global open label trial evaluating 103 patients with unresectable, locally advanced or metastatic intrahepatic (inside the bile ducts of the liver) CCA harboring FGFR2 gene rearrangements, including fusions.
In this trial, patients received LYTGOBI orally once daily at a dose of 20mg until disease progression or unacceptable toxicity. Within Europe, patients were enrolled from France, Germany, Italy, the Netherlands, Spain and the United Kingdom.