Taiho Oncology Europe has announced the launch of Lytgobi (futibatinib) in the United Kingdom for adult patients with locally advanced or metastatic cholangiocarcinoma who have already received at least one line of systemic therapy. The launch follows the conditional marketing authorization granted in September 2024 and a subsequent recommendation from the National Institute for Health and Care Excellence, supporting futibatinib monotherapy as a treatment option for patients with FGFR2 fusions or rearrangements.
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Cholangiocarcinoma is a rare and aggressive cancer of the bile ducts that carry bile from the liver and gallbladder to the small intestine. In 2023, around 3,110 people were diagnosed with cholangiocarcinoma in England. The disease is typically identified at an advanced stage, with a poor prognosis and fewer than one in five patients surviving five years. This creates an urgent need for new treatment options such as futibatinib.
Professor John Bridgewater, Clinical Researcher and Medical Oncologist at University College London Cancer Institute and University College London Hospitals NHS Foundation Trust, highlighted the significance of the launch. He said that patients with cholangiocarcinoma often face a late diagnosis and limited treatment options. He added that the introduction of futibatinib in the UK provides a much-needed additional therapy for eligible patients with this aggressive form of cancer.
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Lytgobi is an oral medication taken once daily and continued until disease progression or unacceptable side effects occur. Its approval is based on the Phase 2 FOENIX-CCA2 global trial, which involved 103 patients with unresectable or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements. The trial demonstrated a 42 percent objective response rate and a median response duration of 9.7 months. The 12-month overall survival rate reached 72 percent.
Common side effects reported in the trial included hyperphosphatemia, nail disorders, constipation, hair loss, diarrhea, dry mouth, fatigue, nausea, dry skin, increased liver enzymes, abdominal pain, stomatitis, vomiting, palmar-plantar erythrodysaesthesia syndrome, joint pain, and decreased appetite. The trial enrolled patients across multiple European countries including France, Germany, Italy, the Netherlands, Spain, and the UK, and its findings were published in The New England Journal of Medicine in 2023.
Dr. Peter Foertig, General Manager of Taiho Oncology Europe, said the UK launch reflects the collaborative efforts of researchers, healthcare professionals, and patients dedicated to improving outcomes for cholangiocarcinoma. He added that this marks Taiho Oncology’s first independent product introduction in the UK, demonstrating the company’s commitment to establishing a strong presence and bringing innovative oral therapies to cancer patients. Futibatinib was developed by Taiho Oncology Europe’s parent company, Taiho Pharmaceutical, based in Tokyo, and the broader Taiho group continues to explore its potential in other tumor types.
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