EMA Recommends Extension of Therapeutic Indications for Venetoclax

New indication concerns a combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy
01 Oct 2018
Haematologic malignancies;  Anticancer agents & Biologic therapy

On 20 September 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product venetoclax (Venclyxto). 

The marketing authorisation holder for this medicinal product is AbbVie Deutschland GmbH & Co. KG. 

The CHMP adopted an extension to the existing indication as follows: 

Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. 

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

Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. 

Venclyxto monotherapy is indicated for the treatment of CLL: 

  • in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or 
  • in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, 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. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

Last update: 01 Oct 2018

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