Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for LYTGOBI (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA).
The authorisation is based on the data from the global, open label FOENIX-CCA2 trial. It enrolled a total of 103 adult patients from the Netherlands, UK, Spain, Italy, France, and Germany.
Patients with unresectable, locally advanced or metastatic intrahepatic CCA harboring FGFR2 gene fusion or rearrangement were enrolled in the study.
They were treated with 20mg LYTGOBI once a day until disease progression or unacceptable toxicity.
The study met the primary endpoint demonstrating an objective response rate of 42%, as assessed by independent review.
It also showed a median duration of response of 9.7 months, a key secondary endpoint.
Patients treated with LYTGOBI showed some most common adverse reactions including alopecia, constipation, diarrhoea, dry mouth, fatigue, hyperphosphatemia, and nail disorders.
Symptoms accompanied include nausea, abdominal pain, arthralgia, dry skin, decreased appetite, increased AST, stomatitis, vomiting, and palmar-plantar erythrodysaesthesia syndrome.
LYTGOBI can cause serous retinal detachment showing symptoms such as visual floaters or photopsia, and blurred vision.
Taiho Oncology Europe chairman and Taiho Pharmaceutical managing director Atsushi Azuma said: “Patients with CCA are often diagnosed at an advanced stage when surgery is not an option.
“We are pleased that LYTGOBI now will be a new treatment option for patients with CCA.”
A rare and aggressive cancer of the bile ducts of the liver, CCA has been diagnosed in around 6.000-8.000 people in Europe.