European Commission grants conditional approval for Lytgobi to treat cholangiocarcinoma .- Taiho Oncology Europe.
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.
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