Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FGFR2 rearrangements 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.