Taiho Oncology Europe Announces the Availability of Lytgobi® (Futibatinib) in Germany for the Treatment of Cholangiocarcinoma.
Wednesday, June 12, 2024
Taiho Oncology Europe GmbH has announced the launch of Lytgobi® (futibatinib) in Germany, following its conditional approval across the European Union. Lytgobi® is a new oral medication designed to inhibit the fibroblast growth factor receptor (FGFR) for adult patients with locally advanced or metastatic cholangiocarcinoma who exhibit FGFR2 fusion or rearrangement and have not responded to previous systemic treatments.
Cholangiocarcinoma is a form of bile duct cancer that is typically detected at an advanced stage, posing significant treatment challenges. In Germany, around 7,700 individuals are diagnosed annually, underlining the urgent need for effective treatment options like futibatinib.
Professor Dr. Arndt Vogel from the Department of Gastroenterology, Hepatology, and Endocrinology at Hannover Medical School emphasized the importance of futibatinib in advancing treatment for this challenging cancer.
Futibatinib works by targeting and irreversibly binding to FGFRs, thereby inhibiting their associated signaling pathways. It is administered orally once daily. The conditional approval in the EU is based on results from the pivotal Phase II FOENIX-CCA2 trial, which involved 103 patients with unresectable intrahepatic cholangiocarcinoma. The trial showed that futibatinib achieved a 42% objective response rate, a median response duration of 9.7 months, and a median overall survival of 20 months. Furthermore, the 12-month survival rate was 73.1%.
Side effects commonly observed with futibatinib include hyperphosphatemia, nail disorders, constipation, alopecia, diarrhea, and fatigue.
Taiho Oncology Europe, highlighted the collaborative efforts that have led to the introduction of futibatinib, marking the first standalone drug launch in Europe for Taiho Oncology.
Developed by Taiho Pharmaceutical Co., Ltd. in Tokyo, futibatinib is also being studied in combination with pembrolizumab for treating various solid tumors. The conditional marketing authorization granted for futibatinib is intended for cases where there is an unmet medical need for treating serious diseases, prioritizing the benefits of early treatment availability while additional evidence is being gathered.
Source: businesswire.com
