Pemazyre

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pemigatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Pemazyre is a cancer medicine used to treat adults with cholangiocarcinoma (biliary tract cancer or cancer of the bile ducts) when the cancer cells have an abnormal form of a receptor (target) called FGFR2 on their surface. Pemazyre is used when the cancer has spread to other parts of the body or cannot be removed by surgery and has worsened after previous treatment with at least one cancer medicine.

Cholangiocarcinoma is rare, and Pemazyre was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 August 2018.

Pemazyre contains the active substance pemigatinib.

This EPAR was last updated on 15/06/2022

Authorisation details

Product details
Name
Pemazyre
Agency product number
EMEA/H/C/005266
Active substance
pemigatinib
International non-proprietary name (INN) or common name
pemigatinib
Therapeutic area (MeSH)
Cholangiocarcinoma
Anatomical therapeutic chemical (ATC) code
L01EX20
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Incyte Biosciences Distribution B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

19/05/2022 Pemazyre - EMEA/H/C/005266 - II/0005

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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