Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations

Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations

Basilea provided expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib was ongoing.

The following inclusion criteria were applied:

• all other treatment options had been exhausted
• patient was ineligible for any ongoing trials or was geographically inaccessible to trials including a trial with derazantinib
• there was a reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
• patient was willing and able to provide written informed consent
• if applicable, regulatory approval by the appropriate jurisdiction was obtained