Regulatory approval

Published by the European Medicines Agency.

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.

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