Pemazyre (pemigatinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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