Pemazyre
pemigatinib
Table of contents
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.
-
List item
Pemazyre : EPAR - Medicine overview (PDF/120.91 KB)
First published: 04/05/2021
EMA/95344/2021 -
-
List item
Pemazyre : EPAR - Risk-management-plan summary (PDF/144.66 KB)
First published: 04/05/2021
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 |
L01EN02
|
Additional 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 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. |
Orphan |
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 |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
26/03/2021
|
Contact address |
Paasheuvelweg 25 |
Product information
26/07/2023 Pemazyre - EMEA/H/C/005266 - PSUSA/00010923/202210
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.