Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FGFR2::v status confers therapeutic sensitivity to Futibatinib in patients with Intrahepatic Cholangiocarcinoma.
The European Medicines Agency (EMA) has given futibatinib conditional market authorization as a monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or rearrangement that have progressed after at least one line of prior systemic therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.