Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has conditionally authorized pemigatinib for the treatment of adult patients 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 as:

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.

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.