Venclyxto - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

venetoclax

Opinion

On 23 April 2026, the 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 Venclyxto. The marketing authorisation holder for this medicinal product is AbbVie Deutschland GmbH & Co. KG.

The CHMP adopted a new indication as follows:

Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1):

• in combination with acalabrutinib with or without obinutuzumab
• in combination with obinutuzumab (see section 5.1).

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.

Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

For information, the CHMP also adopted a change to an existing indication on 23 April 2026 to extend the use of Venclyxto in combination with ibrutinib in adults with previously untreated CLL. Information on this change is provided in a dedicated summary of opinion available on the EMA website.

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

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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Venclyxto (VR-0000322240)

Adopted Reference Number: EMADOC-1700519818-3013050

Key facts

• Name of medicine:
  Venclyxto
• EMA product number:
  EMEA/H/C/004106
• Active substance:
  venetoclax
• International non-proprietary name (INN) or common name:
  venetoclax
• Therapeutic area (MeSH):
  Leukemia, Lymphocytic, Chronic, B-Cell
• Anatomical therapeutical chemical (ATC) code:
  L01XX52
• Marketing authorisation holder:
  AbbVie Deutschland GmbH & Co. KG
• Date of opinion:
  23/04/2026
• Status:
  Positive