Regulatory approval

Published by the Health Canada.

Health Canada approved pemigatinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

This is written in the approval document as:

PEMAZYRE (pemigatinib) is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Citation

Pemazyre (pemigatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00062968.PDF. Published September 2021. Accessed June 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) FGFR2::v Cholangiocarcinoma Pemigatinib
Sensitivity (+) FGFR2 rearrangements Cholangiocarcinoma Pemigatinib