Futibatinib Now Available in Italy for Cholangiocarcinoma Treatment, Announces Taiho Oncology Europe
Taiho Oncology Europe GmbH has announced the availability of futibatinib in Italy for the treatment of cholangiocarcinoma (CCA), a rare and aggressive bile duct cancer. This follows the European Union’s conditional marketing authorization of futibatinib for adult patients with locally advanced or metastatic CCA, who have FGFR2 fusion or rearrangement and have not responded to at least one line of systemic therapy.
CCA, a cancer of the bile ducts, is a serious condition with increasing global incidence. In Italy, approximately 1,710 people are diagnosed with CCA each year. Unfortunately, CCA is typically diagnosed at an advanced stage, with a poor prognosis. Less than 20% of patients survive for five years, highlighting the urgent need for new treatment options. Futibatinib’s availability in Italy represents a significant advancement for patients in need of alternative therapies.
“Patients with CCA are often diagnosed too late, and having more treatment options is critical,” said Professor Lorenza Rimassa, Medical Oncologist at Humanitas University and the Institute for Research and Treatment at Humanitas Research Hospital in Milan. “The introduction of futibatinib brings hope to doctors and patients across Italy.”
Futibatinib works as a targeted therapy by irreversibly binding to the FGFR (fibroblast growth factor receptor) and specifically targeting FGFR fusions or rearrangements. The oral treatment is taken daily, offering a continuous and manageable therapeutic option for patients.
The conditional marketing authorization granted by the EU is based on the results of the pivotal Phase 2 FOENIX-CCA2 study. This open-label study included 103 patients with unresectable, locally advanced or metastatic CCA who had FGFR2 fusion or rearrangement. The results of this study, published in the New England Journal of Medicine, showed promising data and supported the approval of futibatinib. Patients from Italy, France, Germany, Spain, the Netherlands, and the United Kingdom were enrolled in the study.
“This milestone is the result of an extensive collaboration between researchers, healthcare professionals, and patients, all working together to improve the treatment of cholangiocarcinoma,” said Dr. Peter Foertig, General Manager of Taiho Oncology Europe. “The launch of futibatinib is especially significant for Taiho Oncology as it marks the first product we are commercializing in Europe on our own. This is a crucial step for our presence in the region and for our ongoing commitment to bringing innovative therapies to cancer patients.”
Futibatinib was developed by Taiho Oncology’s parent company, Taiho Pharmaceutical Co., Ltd. in Tokyo. The drug has shown to be a potent, selective, irreversible tyrosine kinase inhibitor, targeting FGFR1-4. By binding irreversibly to the adenosine triphosphate-binding pocket of these FGFRs, futibatinib disrupts tumor cell signaling pathways, reduces tumor cell proliferation, and increases tumor cell death in tumors with genetic abnormalities in FGFR1-4.
The EU’s conditional marketing authorization was granted because futibatinib fulfills an unmet medical need for patients with serious diseases. It allows earlier access to the drug, pending further evidence of its long-term safety and effectiveness. This decision is a key step toward addressing the global need for new treatments for aggressive cancers like CCA.
About Futibatinib
Futibatinib is an oral tyrosine kinase inhibitor that specifically targets FGFR1-4. It irreversibly binds to the FGFRs’ adenosine triphosphate-binding pocket, effectively inhibiting signaling pathways that drive tumor growth. This mechanism reduces tumor cell proliferation and enhances tumor cell death, providing a promising treatment option for tumors with FGFR genetic alterations.
About Taiho Oncology Europe
Taiho Oncology Europe is dedicated to improving the lives of cancer patients and their families by providing innovative therapies. Specializing in orally administered anticancer agents, the company has an expanding pipeline of selectively targeted treatments for cancer. Taiho Oncology Europe is a subsidiary of Taiho Pharmaceutical Co., Ltd., based in Tokyo, Japan.
