Pemazyre (pemigatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Incyte Biosciences Distribution B.V. Pemazyre (pemigatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/pemazyre-epar-product-information_en.pdf. Revised September 2023. Accessed March 22, 2024.

Regulatory approvals

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

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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