Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	FGFR2::v	Cholangiocarcinoma	Elacestrant
EMA (1)	FGFR2 rearrangements	Cholangiocarcinoma	Elacestrant

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-03-26	European Medicines Agency	Indication received approval from the European Commission.