Pemazyre
What Pemazyre is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Pemazyre
- Active substance
- pemigatinib
- Disease area
- Cholangiocarcinoma
- Medicine group
- Antineoplastic agents
- ATC code
- L01EN02
- Marketing authorisation holder
- Incyte Biosciences Distribution B.V.
- Authorised in the EU since
- 2021
Official information
In the USA
Same active substance: Pemazyre
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Pemazyre used for?
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.
What is the active substance in Pemazyre?
Pemazyre contains pemigatinib.
Who makes Pemazyre?
The EU marketing authorisation holder is Incyte Biosciences Distribution B.V..
Is Pemazyre an orphan medicine?
Yes. Pemazyre is designated an orphan medicine in the EU, for a rare disease (Cholangiocarcinoma).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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