Taiho Oncology Europe Launches Lytgobi® (Futibatinib) in Spain for Cholangiocarcinoma Therapy
Friday, August 02, 2024
Taiho Oncology Europe GmbH has introduced Lytgobi® (futibatinib) in Spain, following its conditional marketing authorization in the European Union. This innovative drug is a non-reversibly binding fibroblast growth factor receptor (FGFR) inhibitor, approved for treating adults with locally advanced or metastatic cholangiocarcinoma (CCA) who have FGFR2 fusion or rearrangement and have experienced progression after at least one prior systemic therapy.
Cholangiocarcinoma is a challenging cancer of the bile ducts, with approximately 2,648 new cases annually in Spain. The incidence is increasing globally, and the disease is frequently diagnosed at an advanced stage with a poor prognosis, highlighting the urgent need for new treatments like futibatinib.
Elisabeth Baucells of the newly established Association of Biliary Tract Tumors (ATUVIBI) noted that such advancements offer hope and support to patients and their families. Dr. Teresa Macarulla, a medical oncologist at Hospital Universitari Vall d'Hebron in Barcelona, emphasized that futibatinib represents a significant progress in the management of CCA.
Futibatinib works by irreversibly binding to FGFR, targeting specific FGFR fusions or rearrangements, and is administered orally once a day. The conditional marketing authorization in Europe is based on results from the global Phase II FOENIX-CCA2 trial, which included 103 patients with unresectable, locally advanced, or metastatic CCA. The trial showed a 42% objective response rate, a median duration of response of 9.7 months, a median overall survival of 20.0 months, and a 12-month overall survival rate of 73.1%.
The most frequently reported side effects include hyperphosphatemia, nail disorders, constipation, alopecia, and diarrhea. The FOENIX-CCA2 trial results were published in The New England Journal of Medicine.
Taiho Oncology Europe, described the launch of futibatinib as a key milestone and the first product launched by Taiho independently in Europe. This marks an important step in expanding Taiho’s presence in the European market and their commitment to providing innovative cancer treatments.
Futibatinib, developed by Taiho Pharmaceutical Co., Ltd. in Tokyo, is also under investigation in combination with pembrolizumab for other solid tumors.
Source: businesswire.com
