Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FGFR2::v status confers therapeutic sensitivity to Elacestrant in patients with Intrahepatic Cholangiocarcinoma.
The European Medicines Agency (EMA) has conditionally authorized pemigatinib 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.
This statement is based on a regulatory approval from the European Medicines Agency:
Pemazyre monotherapy is indicated for the treatment of adults 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.