Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	FGFR2::v	Cholangiocarcinoma	Pemigatinib
HC (1)	FGFR2 rearrangements	Cholangiocarcinoma	Pemigatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals