Zydelig

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idelalisib

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

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.

This EPAR was last updated on 10/01/2020

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)
  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XX47
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.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
18/09/2014
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

14/11/2019 Zydelig - EMEA/H/C/003843 - II/0047

Contents

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Pharmacotherapeutic group

  • Antineoplastic agents

  • 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 (see section 4.4), or
  • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).

Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).

Assessment history

Changes since initial authorisation of medicine

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