Zydelig
idelalisib
Table of contents
Overview
Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients whose cancer cells have genetic mutations (changes) called 17p deletion or TP53 mutation and who cannot be treated with any other therapy.
In follicular lymphoma, Zydelig is used on its own in patients whose disease has not improved with two previous treatments.
Zydelig contains the active substance idelalisib.
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Zydelig : EPAR - Medicine overview (PDF/131.82 KB)
First published: 14/10/2014
Last updated: 10/01/2020 -
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Zydelig : EPAR - Risk-management-plan summary (PDF/79.16 KB)
First published: 14/10/2014
Last updated: 20/05/2021
Authorisation details
| Product details | |
|---|---|
| Name |
Zydelig
|
| Agency product number |
EMEA/H/C/003843
|
| Active substance |
Idelalisib
|
| International non-proprietary name (INN) or common name |
idelalisib
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01XX47
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
| Revision |
19
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/09/2014
|
| Contact address |
IDA Business & Technology Park |
Product information
29/09/2021 Zydelig - EMEA/H/C/003843 - IA/0053
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
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Antineoplastic agents
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Other antineoplastic agents
Therapeutic indication
Zydelig is indicated in combination with an anti‑CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
- who have received at least one prior therapy, or
- as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.