Zydelig

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Questions & Answers

On 25 February 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension of the indication for the medicinal product Zydelig.

The marketing authorisation holder for this medicinal product is Gilead Sciences International Ltd.

On 21 July 2016, the Committee adopted another opinion recommending further changes to the indication in relation to an evaluation under Article 20 of Regulation (EC) No 726/2004.

As a result the existing indication will change as follows1:

'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 unsuitable for chemo‑immunotherapywho are not eligible for any other therapies.'

For information, the full indications for Zydelig will be as follows:

'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.'

Changes were also made to section 4.4 (Special warnings and precautions for use) and 4.8 (Adverse effects). 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold, deleted text in strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Zydelig (English only) 22/07/2016  

Key facts

Product details for Zydelig
NameZydelig
INN or common name

idelalisib

Therapeutic area Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell
Active substance

idelalisib

Date opinion adopted21/07/2016
Company name

Gilead Sciences International Ltd

StatusPositive
Application typePost authorisation

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